+-----------------------+-----------------------+-----------------------+
| **Firm Name:**        |                       |                       |
| **FEI Number:**       |                       |                       |
|                       |                       |                       |
| **Inspection          |                       |                       |
| Date(s):**            |                       |                       |
| **FCE Number:**       |                       |                       |
|                       |                       |                       |
| **Investigators:**    |                       |                       |
|                       |                       |                       |
+-----------------------+-----------------------+-----------------------+
| DEPARTMENT OF HEALTH  |                       |                       |
| AND HUMAN SERVICES    |                       |                       |
|                       |                       |                       |
| FOOD AND DRUG         |                       |                       |
| ADMINISTRATION        |                       |                       |
|                       |                       |                       |
| **ASEPTIC PROCESSING  |                       |                       |
| & PACKAGING REPORT**  |                       |                       |
+-----------------------+-----------------------+-----------------------+
| This inspection       |                       |                       |
| report is available   |                       |                       |
| in PDF and M.S. Word  |                       |                       |
| on the forms site:    |                       |                       |
| *http://w             |                       |                       |
| ww.fda.gov/opacommore |                       |                       |
| choic                 |                       |                       |
| es/fdaforms/ora.html* |                       |                       |
| (only the M.S. Word   |                       |                       |
| version has           |                       |                       |
| expandable fields).   |                       |                       |
| Narrative responses   |                       |                       |
| to each item can be   |                       |                       |
| entered in the item's |                       |                       |
| "comments" area or    |                       |                       |
| where otherwise       |                       |                       |
| prompted. Complete    |                       |                       |
| documentation of      |                       |                       |
| deficiencies          |                       |                       |
| including deviations  |                       |                       |
| from Part 113 should  |                       |                       |
| be narrated with      |                       |                       |
| reference to photos,  |                       |                       |
| exhibits, etc, in the |                       |                       |
| Turbo EIR under       |                       |                       |
| "Objectionable        |                       |                       |
| Conditions and        |                       |                       |
| Management's          |                       |                       |
| Response". When       |                       |                       |
| necessary, refer the  |                       |                       |
| reader to the         |                       |                       |
| appropriate section   |                       |                       |
| of the Turbo EIR for  |                       |                       |
| a full explanation of |                       |                       |
| details.              |                       |                       |
|                       |                       |                       |
| This form should be   |                       |                       |
| downloaded from the   |                       |                       |
| forms site to a       |                       |                       |
| computer drive prior  |                       |                       |
| to completion and     |                       |                       |
| copying. The finished |                       |                       |
| report should be      |                       |                       |
| submitted as an       |                       |                       |
| attachment to the     |                       |                       |
| Turbo EIR.            |                       |                       |
+-----------------------+-----------------------+-----------------------+
| **ESTABLISHMENT       |                       |                       |
| REGISTRATION --       |                       |                       |
| 108.35(c)(1)**        |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 1\. HAS THE FIRM      |                       |                       |
| REGISTERED THEIR      |                       |                       |
| PROCESSING            |                       |                       |
| ESTABLISHMENT WITH    |                       |                       |
| FDA? Yes No           |                       |                       |
|                       |                       |                       |
| IF FIRM HAS           |                       |                       |
| REGISTERED, THE FCE   |                       |                       |
| NO. IS                |                       |                       |
| [     ]{.underline}.  |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| **PROCESS             |                       |                       |
| ESTABLISHMENT &       |                       |                       |
| FILING --             |                       |                       |
| 108.35(c)(2),         |                       |                       |
| 113.83**              |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 2\. HAVE SCHEDULED    |                       |                       |
| PROCESSES BEEN FILED  |                       |                       |
| WITH FDA LISTING ALL  |                       |                       |
| CRITICAL FACTORS      |                       |                       |
| NECESSARY TO ACHIEVE  |                       |                       |
| COMMERCIAL STERILITY  |                       |                       |
| FOR THE PRODUCT, THE  |                       |                       |
| PRODUCT STERILIZATION |                       |                       |
| SYSTEM, THE\          |                       |                       |
| PACKAGING             |                       |                       |
| STERILIZATION SYSTEM  |                       |                       |
| AND THE PACKAGING     |                       |                       |
| MATERIAL? Yes No      |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 3\. HAVE SCHEDULED    |                       |                       |
| PROCESSES USED BY THE |                       |                       |
| FIRM BEEN RECOMMENDED |                       |                       |
| BY A PROCESS          |                       |                       |
| AUTHORITY\            |                       |                       |
| (LETTER, BULLETIN,    |                       |                       |
| SOP MANUAL, ETC.)?    |                       |                       |
| Yes No                |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 4\. DOES THE FIRM     |                       |                       |
| HAVE A PROCESS LETTER |                       |                       |
| OR OTHER              |                       |                       |
| DOCUMENTATION LISTING |                       |                       |
| CRITICAL FACTORS      |                       |                       |
| NECESSARY TO CONTROL  |                       |                       |
| IN THE ATTAINMENT OF  |                       |                       |
| COMMERCIAL STERILITY? |                       |                       |
| Yes No                |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 5\. ARE FILED         |                       |                       |
| PROCESSES AT LEAST    |                       |                       |
| EQUAL TO RECOMMENDED  |                       |                       |
| PROCESSES PROVIDED BY |                       |                       |
| THE PROCESS           |                       |                       |
| AUTHORITY? Yes No     |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 6\. DOES THE FIRM     |                       |                       |
| HAVE ON FILE          |                       |                       |
| SUPPLEMENTAL          |                       |                       |
| INFORMATION LISTING   |                       |                       |
| PROCEDURES FOR PRE-\  |                       |                       |
| STERILIZATION AND     |                       |                       |
| STERILITY MAINTENANCE |                       |                       |
| OF PROCESSING AND     |                       |                       |
| PACKAGING EQUIPMENT   |                       |                       |
| AND STERILIZATION OF  |                       |                       |
| PACKAGING MATERIAL?   |                       |                       |
| Yes No                |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 7\. HAVE FILED,       |                       |                       |
| SCHEDULED PROCESSES   |                       |                       |
| BEEN CHANGED IN SUCH  |                       |                       |
| A WAY THAT COULD      |                       |                       |
| AFFECT THE\           |                       |                       |
| ATTAINMENT OF         |                       |                       |
| COMMERCIAL STERILITY? |                       |                       |
| Yes No                |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 8\. IF PROCESS        |                       |                       |
| CHANGES HAVE BEEN     |                       |                       |
| MADE THAT COULD       |                       |                       |
| AFFECT THE ATTAINMENT |                       |                       |
| OF COMMERCIAL         |                       |                       |
| STERILITY, HAVE THE   |                       |                       |
| CHANGES BEEN REVIEWED |                       |                       |
| AND SUBSTANTIATED BY  |                       |                       |
| A QUALIFIED           |                       |                       |
| SCIENTIFIC\           |                       |                       |
| AUTHORITY AND FILED   |                       |                       |
| WITH FDA? Yes No      |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 9\. LIST THE FIRM'S   |                       |                       |
| PROCESS AUTHORITIES:  |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 10\. ARE PROCESS      |                       |                       |
| AUTHORITIES THE SAME  |                       |                       |
| AS THOSE FILED WITH   |                       |                       |
| FDA? Yes No           |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 11\. LIST ALL         |                       |                       |
| PRODUCTS COVERED      |                       |                       |
| DURING THIS           |                       |                       |
| INSPECTION:           |                       |                       |
+-----------------------+-----------------------+-----------------------+
| > ***PRODUCT***       | > ***STYLE OF PACK*** | ***CONTAINER          |
|                       |                       | TYPE/SIZE***          |
+-----------------------+-----------------------+-----------------------+
| >                     | >                     |                       |
+-----------------------+-----------------------+-----------------------+
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 12\. LIST ALL FACTORS |                       |                       |
| CRITICAL TO THE       |                       |                       |
| ATTAINMENT AND        |                       |                       |
| MAINTENANCE OF        |                       |                       |
| COMMERCIAL STERILITY\ |                       |                       |
| PER PROCESS AUTHORITY |                       |                       |
| LETTER AND FDA FILING |                       |                       |
| FORMS FOR PRODUCTS    |                       |                       |
| COVERED DURING THIS   |                       |                       |
| INSPECTION (INCLUDE   |                       |                       |
| PRESTERILIZATION AND  |                       |                       |
| MAINTENANCE OF        |                       |                       |
| STERILITY IN THE      |                       |                       |
| ASEPTIC PROCESSING\   |                       |                       |
| AND PACKAGING SYSTEMS |                       |                       |
| AND SURGE TANKS AS    |                       |                       |
| WELL AS THE           |                       |                       |
| PROCESSING, PACKAGING |                       |                       |
| AND HOLDING\          |                       |                       |
| OF PRODUCTS IN THESE  |                       |                       |
| SYSTEMS):             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| **RAW MATERIALS**     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 13\. DOES THE FIRM    |                       |                       |
| TAKE ADEQUATE         |                       |                       |
| MEASURES TO PREVENT   |                       |                       |
| THE BUILD-UP OF       |                       |                       |
| MICROORGANISMS IN     |                       |                       |
| UNPROCESSED PRODUCT   |                       |                       |
| BEFORE THERMAL        |                       |                       |
| PROCESSING? Yes No    |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 14\. WHAT IS THE      |                       |                       |
| SOURCE OF WATER USED  |                       |                       |
| FOR PROCESSING AND    |                       |                       |
| CLEAN UP IN THE       |                       |                       |
| PLANT?                |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+
| 15\. IS PLANT WATER   |                       |                       |
| ADEQUATELY TREATED    |                       |                       |
| WITH CHLORINE OR      |                       |                       |
| OTHER APPROVED        |                       |                       |
| CHEMICALS TO RENDER   |                       |                       |
| IT POTABLE? Yes No    |                       |                       |
|                       |                       |                       |
| COMMENTS:             |                       |                       |
|                       |                       |                       |
| >                     |                       |                       |
+-----------------------+-----------------------+-----------------------+

+-----------------------------------------------------------------------+
| 16\. ARE ALL FOOD AND COLOR ADDITIVES FDA APPROVED? Yes No            |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **PRODUCT PREPARATION -- 113.81**                                     |
+-----------------------------------------------------------------------+
| 17\. ARE PRODUCTS PREPARED ACCORDING TO THE METHOD AND/OR FORMULATION |
| SPECIFIED IN THE RECOMMENDED SCHEDULED PROCESS? Yes No                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 18\. ARE INGREDIENTS WEIGHED PROPERLY USING ACCURATE SCALES: Yes No   |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **PRODUCT STERILIZATION EQUIPMENT AND CONTROLS**                      |
+-----------------------------------------------------------------------+
| ***TEMPERATURE INDICATING DEVICE -- 113.40(g)(1)(i)(a)***             |
+-----------------------------------------------------------------------+
| 19\. IS THE PRODUCT STERILIZER EQUIPPED WITH AT LEAST 1               |
| MERCURY-IN-GLASS THERMOMETER OR EQUIVALENT TEMPERATURE-INDICATING     |
| DEVICE (TID) THAT COMPLIES WITH PART 113.40(g)(1)(i)(a)?              |
|                                                                       |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 20\. IS THE TID CHECKED FOR ACCURACY AT LEAST ONCE PER YEAR &         |
| DOCUMENTED PER PART\                                                  |
| 113.40(g)(1)(i)(a)? Yes No                                            |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***TEMPERATURE RECORDING DEVICE -- 113.40(g)(1)(i)(b)***              |
+-----------------------------------------------------------------------+
| 21\. IS THE PRODUCT STERILIZER EQUIPPED WITH A TEMPERATURE RECORDING  |
| DEVICE INSTALLED IN THE PRODUCT FLOW AT THE HOLDING-TUBE OUTLET       |
| BETWEEN THE HOLDING TUBE AND THE INLET TO THE COOLER? Yes No          |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 22\. IS THE TEMPERATURE RECORDING DEVICE ADJUSTED TO AGREE AS NEARLY  |
| AS POSSIBLE WITH BUT\                                                 |
| NEVER HIGHER THAN A KNOWN ACCURATE MERCURY-IN-GLASS THERMOMETER? Yes  |
| No                                                                    |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 23\. DOES THE TEMPERATURE RECORDING DEVICE COMPLY WITH ALL            |
| REQUIREMENTS OF 113.40(g) (1)(i)(b)? Yes No                           |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***TEMPERATURE RECORDER CONTROLLER (TRC) -- 113.40(g)(1)(i)(c)***     |
+-----------------------------------------------------------------------+
| 24\. IS THE TRC INSTALLED IN THE PRODUCT STERILIZER AT THE FINAL      |
| HEATER OUTLET? Yes No                                                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 25\. DOES THE TRC MEET THE REQUIREMENTS OF 113.40(g)(1)(i)(c)? Yes No |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 26\. DESCRIBE HOW THE TEMPERATURE RECORDER DEVICE IS CHECKED FOR      |
| ACCURACY:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***METERING (TIMING) PUMP -- 113.40 (g) (1) (i) (f)***                |
+-----------------------------------------------------------------------+
| 27\. DESCRIBE THE TYPE OF METERING PUMP:                              |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 28\. IS THE PUMP LOCATED UPSTREAM FROM THE HOLD TUBE? Yes No          |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 29\. THE PUMP IS Fixed Rate Variable Rate                             |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 30\. IS THERE A MEANS OF PREVENTING UNAUTHORIZED SPEED CHANGES? Yes   |
| No                                                                    |
|                                                                       |
| IF YES, WHAT ARE THE MEANS FOR PREVENTING UNAUTHORIZED SPEED CHANGES? |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 31\. IF THE PUMP IS OTHER THAN A POSITIVE DISPLACEMENT TYPE, WHAT     |
| EVIDENCE DOES THE FIRM HAVE\                                          |
| THAT IT IS CAPABLE OF MAINTAINING THE REQUIRED RATE OF PRODUCT FLOW?  |
|                                                                       |
| DOES THE FIRM USE A FLOW METER TO RECORD OR REGULATE PRODUCT FLOW?    |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 32\. IF A FLOW METER IS USED, LIST THE FLOW METER MAKE AND MODEL NO.  |
| AND EXPLAIN HOW IT IS USED:                                           |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 33\. WHAT PROCEDURES ARE USED TO VALIDATE THE FLOW RATE? (PUMP        |
| STROKES, CONTAINERS OR GAL/TIME PERIOD, TACHOMETER, ETC):             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 34\. HAS THE PROCESSOR DOCUMENTED THAT THE FLOW RATE AND FLOW         |
| CHARACTERISTICS OF THE\                                               |
| PRODUCT ARE THE SAME AS THOSE ESTABLISHED BY THE PROCESS AUTHORITY?   |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 35\. IS THE PRODUCT FLOW RATE MONITORED AND DOCUMENTED BY THE         |
| PROCESSOR AS A ROUTINE PART OF THE SYSTEM OPERATION? Yes No           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 36\. HOW IS THE FLOW METER SYSTEM MAINTAINED?                         |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***PRODUCT HEATER***                                                  |
+-----------------------------------------------------------------------+
| 37\. IS THE PRODUCT HEATING SYSTEM:                                   |
|                                                                       |
| Steam Injection Steam Infusion Plate Heat                             |
|                                                                       |
| Tubular or Scrapped Surface Heat Exchanger OHMIC                      |
|                                                                       |
| Other Explain:                                                        |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***PRODUCT TO PRODUCT REGENERATOR -- 113.40(g)(1)(i)(d)***            |
+-----------------------------------------------------------------------+
| 38\. IF A PRODUCT TO PRODUCT REGENERATOR IS USED, IS IT EQUIPPED WITH |
| A PRESSURE DIFFERENTIAL RECORDER CONTROLLER TO ASSURE THAT THE        |
| PRESSURE OF THE STERILIZED PRODUCT IN THE REGENTERATOR IS GREATER     |
| THAN THE PRESSURE OF ANY UNSTERILIZED PRODUCT IN THE\                 |
| REGENERATOR? Yes No Regenerator Not Used                              |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >      \                                                              |
| > \                                                                   |
| > IF YES, DOES THE DIFFERENTIAL PRESSURE RECORDER CONTROLLER COMPLY   |
| > WITH Part 113.40(g)(1)(i)(e)?\                                      |
| > \                                                                   |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| 39\. HAS THE PRESSURE DIFFERENTIAL RECORDER BEEN TESTED FOR ACCURACY? |
| -- 113.40(g)(1)(I)(e)\                                                |
| Yes No N/A                                                            |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >      \                                                              |
| > \                                                                   |
| > IF SO, LIST THE TEST DATE: [     ]{.underline}                      |
+-----------------------------------------------------------------------+
| ***STERILIZER (PRODUCT HOLDING TUBE) -- 113.40(g)(1)(i)(g)***         |
+-----------------------------------------------------------------------+
| 40\. IS IT SLOPED UPWARD AT LEAST 0.25 IN./FT? Yes No                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 41\. IF DISASSEMBLED FOR CLEANING, HOW DOES THE FIRM ASSURE AFTER     |
| REASSEMBLY THAT IT CONFORMS\                                          |
| TO THE SCHEDULED PROCESS PARAMETERS?                                  |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 42\. DOES THE HOLD TUBE DIAMETER AND LENGTH CONFORM TO THAT LISTED IN |
| THE FILED SCHEDULED PROCESS? Yes No                                   |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 43\. IS IT DESIGNED SO THAT NO PORTION OF TUBE CAN BE HEATED BETWEEN  |
| PRODUCT INLET & OUTLET?                                               |
|                                                                       |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **EQUIPMENT DOWNSTREAM FROM THE HOLDING TUBE**                        |
+-----------------------------------------------------------------------+
| ***FLOW DIVERSION SYSTEM -- 13.40(g)(1)(i)(h)***                      |
+-----------------------------------------------------------------------+
| 44\. IS THE ASEPTIC PROCESSING SYSTEM EQUIPPED WITH A FLOW DIVERSION  |
| VALVE? Yes No                                                         |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 45\. IF PRESENT, IS IT INSTALLED IN THE PRODUCT PIPING LOCATED        |
| BETWEEN THE PRODUCT COOLER AND THE PRODUCT FILLER OR ASEPTIC SURGE    |
| TANK? Yes No                                                          |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 46\. IS IT DESIGNED TO AUTOMATICALLY DIVERT FLOW AWAY FROM THE FILLER |
| OR ASEPTIC SURGE TANK? Yes No                                         |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 47\. IS IT DESIGNED/INSTALLED WITH NECESSARY SENSORS & ACTUATORS TO   |
| OPERATE WHENEVER\                                                     |
| THE STERILIZING TEMPERATURE IN THE HOLD TUBE OR PRESSURE DIFFERENTIAL |
| IN THE PRODUCT REGENERATOR DROPS BELOW SPECIFIED LIMITS? Yes No       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 48\. IS IT DESIGNED/OPERATED IN ACCORDANCE WITH RECOMMENDATIONS OF AN |
| ASEPTIC PROCESSING & PACKAGING AUTHORITY? Yes No                      |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 49\. DESCRIBE THE FIRM'S METHOD FOR DIVERTING NON-STERILE PRODUCT     |
| AWAY FROM THE FILLER OR\                                              |
| ASEPTIC SURGE TANK INCLUDING ANY DOCUMENTATION FROM A PROCESSING      |
| AUTHORITY THAT MAY LIST SPECIFIC RECOMMENDATIONS FOR THE DESIGN AND   |
| OPERATION OF THE SYSTEM:                                              |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 50\. DESCRIBE HOW FLOW DIVERSION INCIDENTS ARE DOCUMENTED INCLUDING   |
| CORRECTIVE ACTION AND DISPOSITION OF DIVERTED PRODUCT:                |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***STEAM SEALS -- 113.40(g)(1)(i)(i)***                               |
+-----------------------------------------------------------------------+
| 51\. ARE ROTATING OR RECIPROCATING SHAFTS AND VALVE STEMS EQUIPPED    |
| WITH STEAM SEALS OR OTHER EFFECTIVE BARRIERS AT POTENTIAL ACCESS      |
| POINTS? Yes No                                                        |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 52\. DOES THE FIRM MAINTAIN A RECORD SHOWING OBSERVATION OF THE STEAM |
| SEALS FOR PROPER OPERATION? Yes No                                    |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***ASEPTIC SURGE TANKS -- 108.35(c)(2); 113.40(g)(1)(ii)***           |
+-----------------------------------------------------------------------+
| 53\. DOES THE FIRM HAVE DOCUMENTATION FROM THEIR PROCESS AUTHORITY    |
| SPECIFYING THE\                                                       |
| STERILIZATION PROCEDURE? Yes No                                       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 54\. ARE THEY ADEQUATELY VENTED OR PURGED OF AIR PRIOR TO             |
| STERILIZATION? Yes No                                                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 55\. ARE THEY STERILIZED WITH Steam or Hot Water                      |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 56\. HAVE VENT/PURGE AND STERILIZATION PROCEDURES & SCHEDULES BEEN    |
| ESTABLISHED BY A PROCESS AUTHORITY? Yes No                            |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 57\. IS STERILE AIR OVER-PRESSURE MAINTAINED ON ASEPTIC SURGE TANKS?  |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 58\. IS STERILE AIR PRODUCED BY Incineration Filtration Other ?       |
|                                                                       |
| > Explain Other:                                                      |
| >                                                                     |
| >                                                                     |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 59\. HOW DOES THE FIRM MONITOR STERILE AIR OR GAS OVER-PRESSURE AND   |
| THEIR METHOD OF ACHIEVING STERILITY?                                  |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 60\. WHAT TYPE OF FILTER SYSTEM IS USED TO STERILIZE THE AIR          |
|                                                                       |
| Heppa (Box) Cartridge Sterilizing (Capable of being sterilized)       |
| Non-Sterilizing                                                       |
|                                                                       |
| *(For example, the box filter is generally sterilized with a chemical |
| or dry heat---steam or hot water potentially will affect its          |
| integrity and should be avoided; cartridge filters are designed to be |
| used either for liquids or air and can be sterilized many different   |
| ways but moist\                                                       |
| heat and steam are preferred.)*                                       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 61\. IF A STERILE FILTER IS USED, WHAT ARE THE FILTER SPECIFICATIONS? |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 62\. DOES THE FIRM HAVE EVIDENCE THAT WATER WILL OR WILL NOT EFFECT   |
| THE AIR FILTERATION PERFORMANCE OF THE FILTER? Yes No                 |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 63\. HOW OFTEN ARE FILTERS CHANGED?                                   |
|                                                                       |
| >                                                                     |
|                                                                       |
| IS THIS FREQUENCY CONSISTENT WITH THE MANUFACTURER OR PROCESS         |
| AUTHORITY\                                                            |
| RECOMMENDATIONS? Yes No                                               |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 64\. ARE ASEPTIC FILTER CHANGES DOCUMENTED ON PROCESSING RECORDS? Yes |
| No                                                                    |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 65\. HAS THE PROCESS AUTHORITY, THE FILTER MANUFACTURER OR THE FIRM   |
| TOOK INTO ACCOUNT THE\                                                |
| AFFECT OF INCINERATED AIR OR STEAM ON THE INTEGRITY OF FILTERS? Yes   |
| No                                                                    |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 66\. DOES THE FIRM HAVE A PROCEDURE FOR DETERMINING THE INTEGRITY OF  |
| FILTERS? Yes No                                                       |
|                                                                       |
| IF YES, WHAT IS THE PROCEDURE AND IS IT CONSISTENT WITH THE           |
| PROCEDURES RECOMMENDED BY THE FILTER SUPPLIER AND/OR PROCESS          |
| AUTHORITY?                                                            |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 67\. WHAT IS THE FIRM'S PROCEDURE FOR ENSURING THE STERILITY OF       |
| OVER-PRESSURE GASES AND ANY FILTERS USED TO FILTER THE STERILE        |
| GASSES?                                                               |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 68\. DO RECORDS INDICATE LOSS OF STERILITY IN THE SURGE TANK 113.40   |
| (g) (1) (ii) (d) Yes No                                               |
|                                                                       |
| IF YES, WAS THE INCIDENT RECORDED AN HANDLED AS A PROCESS DEVIATION?  |
| -- 113.40 (g) (1) (ii) (d)                                            |
|                                                                       |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **PROCESS CONTROL SYSTEMS**                                           |
+-----------------------------------------------------------------------+
| 69\. ARE PRODUCT HEATING AND STERILIZATION SYSTEMS CONTROLLED         |
| Manually or by Computer ?                                             |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 70\. WERE COMPUTERIZED CONTROL SYSTEMS VALIDATED UPON INSTALLATION TO |
| INSURE THAT THEY\                                                     |
| OPERATE AS DESIGNED? Yes No                                           |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 71\. ARE AUTOMATED SYSTEMS ROUTINELY CHALLENGED/CALIBRATED TO VERIFY  |
| THAT PRODUCTS RECEIVE\                                                |
| THE SCHEDULED PROCESS? Yes No                                         |
|                                                                       |
| IF YES, WHEN WAS THE LAST CALIBRATION PERFORMED? [     ]{.underline}  |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 72\. OBTAIN AS AN EXHIBIT A COPY OF THE MOST RECENT                   |
| CHALLENGE/CALIBRATION RECORD FOR THE AUTOMATIC CONTROLS (INCLUDED     |
| SHOULD BE THE METHODOLOGY EMPLOYED, THE TESTING FREQUENCY,            |
| INDIVIDUALS WHO CONDUCTED THE TEST AND THE TEST RESULTS). Yes No      |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 73\. DOES THE FIRM HAVE DOCUMENTATION SHOWING THE VALIDATION OF       |
| STERILIZATION PROCEDURES\                                             |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **ASEPTIC PROCESSING RECORDS 113.40 (g) (1) (ii) (e)**                |
+-----------------------------------------------------------------------+
| 74\. ARE RECORDS MAINTAINED AT THE FOLLOWING POINTS AT STARTUP AND    |
| WITH SUFFICIENT FREQUENCY\                                            |
| TO INSURE THAT THE PROCESS MEETS THE PARAMETERS OF THE SCHEDULED      |
| PROCESS?                                                              |
|                                                                       |
| TEMPERATURE INDICATING DEVICE IN THE HOLDING TUBE OUTLET Yes No       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| TEMPERATURE RECORDER IN THE HOLDING TUBE OUTLET Yes No                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| TEMPERATURE RECORDER-CONTROLLER IN THE FINAL PRODUCT HEATER OUTLET    |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| DIFFERENTIAL PRESSURE RECORDER IF A PRODUCT REGENERATOR IS USED Yes   |
| No                                                                    |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| PRODUCT FLOW RATE AS DETERMINED BY THE METERING PUMP OR AS DETERMINED |
| BY FILLING AND\                                                       |
| CLOSING RATES Yes No                                                  |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| ASEPTIC SURGE TANK STERILE AIR OVERPRESSURE OR OTHER PROTECTIVE MEANS |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| PROPER PERFORMANCE OF STEAM SEALS OR OTHER SIMILAR DEVICES Yes No     |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| THE STERILIZATION OF PROCESSING EQUIPMENT OR "PRESTERILIZATION CYCLE" |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **PRODUCT STERILIZER OPERATION**                                      |
+-----------------------------------------------------------------------+
| ***START-UP -- 113.40(g)(1)(ii)(a)***                                 |
+-----------------------------------------------------------------------+
| 75\. BEFORE THE START OF ASEPTIC PROCESSING OPERATIONS, IS THE        |
| PRODUCT STERILIZER AND ALL\                                           |
| PRODUCT CONTACT SURFACES DOWNSTREAM BROUGHT TO A CONDITION OF         |
| COMMERCIAL STERILITY? -- 113.40(G)(1)(II) Yes No                      |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***PRODUCT TO PRODUCT REGENERATOR -- 113.40(g)(1)(ii)(c)***           |
+-----------------------------------------------------------------------+
| 76\. DO RECORDS INDICATE PRESSURE ON THE STERILE SIDE OF THE          |
| REGENERATOR LESS THAN 1 LB. PER SQ. INCH GREATER THAN PRESSURE ON THE |
| NON-STERILE SIDE OF THE GENERATOR? Yes No                             |
|                                                                       |
| IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? Yes  |
| No                                                                    |
|                                                                       |
| IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS":         |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 77\. IS A PRODUCT TO PRODUCT REGENERATOR USED? Yes No                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***PROPER SPEED OF METERING PUMP -- 113.40(g)(1)(i)(f)***             |
+-----------------------------------------------------------------------+
| 78\. WAS THE METERING PUMP OPERATING PROPERLY TO ASSURE NO MORE THAN  |
| THE MAXIMUM PRODUCT\                                                  |
| FLOW RATE (PROPER RESIDENCE TIME) IN THE HOLDING TUBE? Yes No         |
|                                                                       |
| IF NO, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? Yes   |
| No                                                                    |
|                                                                       |
| IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS":         |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***TEMPERATURE DROP IN PRODUCT STERILIZING HOLD TUBE --               |
| 113.40(g)1)(ii)***                                                    |
+-----------------------------------------------------------------------+
| 79\. WERE THERE ANY INCIDENCES OF TEMPERATURE DROPS IN THE HOLD TUBE  |
| BELOW THAT SPECIFIED IN\                                              |
| THE SCHEDULED PROCESS? Yes No                                         |
|                                                                       |
| IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? Yes  |
| No                                                                    |
|                                                                       |
| IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS":         |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***BACK-PRESSURE VALVES/ORIFICES***                                   |
+-----------------------------------------------------------------------+
| 80\. WHERE ARE BACKPRESSURE VALVES/ORIFICES LOCATED IN THE ASEPTIC    |
| PROCESSING SYSTEM?                                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 81\. HOW DOES FIRM MONITOR THE PROPER FUNCTIONING OF BACKPRESSURE     |
| VALVES?                                                               |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 82\. WERE BACKPRESSURE VALVES OPERATING PROPERLY DURING THE           |
| INSPECTION? Yes No                                                    |
|                                                                       |
| IF NO, REPORT ANY INCIDENCES OF PROCESS DEVIATIONS UNDER "PROCESS     |
| DEVIATIONS":                                                          |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***LOSS OF STERILE AIR PRESSURE OR OTHER PROTECTIVE LEVELS IN ASEPTIC |
| SURGE TANKS -- 113.40(g)(1)(ii)(c)***                                 |
+-----------------------------------------------------------------------+
| 83\. WERE THERE ANY INCIDENCES OF LOSS OF COMMERICAL STERILITY IN     |
| ASEPTIC SURGE TANKS BECAUSE\                                          |
| OF LOSS OF STERILE AIR OVERPRESSURE OR OTHER PROTECTIVE LEVELS? Yes   |
| No                                                                    |
|                                                                       |
| IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? Yes  |
| No \                                                                  |
| IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS":         |
|                                                                       |
| >                                                                     |
|                                                                       |
| OTHER COMMENTS:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***RECORDING DEVICE -- 113.40(2)(i)(a)***                             |
+-----------------------------------------------------------------------+
| 84\. IS THE CONTAINER AND PACKAGING CLOSURE STERILIZATION SYSTEM AND  |
| PRODUCT FILLING AND\                                                  |
| CLOSING SYSTEM INSTRUMENTED TO DEMONSTRATE THAT THE REQUIRED          |
| STERILIZATION IS BEING ACCOMPLISHED CONTINUOUSLY? Yes No              |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 85\. IS THERE ANY DOCUMENTATION SHOWING THAT COMMERCIALLY STERILE     |
| CONDITIONS ARE ACHIEVED AND MAINTAINED? Yes No                        |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 86\. IS THERE ANY DOCUMENTATION SHOWING THE VALIDATION OF STERILIZING |
| CONDTIONS?\                                                           |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **CONTAINER STERILIZING, FILLING AND CLOSING OPERATIONS --            |
| 113.40(g)(2)**                                                        |
+-----------------------------------------------------------------------+
| ***EQUIPMENT***                                                       |
+-----------------------------------------------------------------------+
| 87\. DO THE FIRM'S PROCEDURES ENSURE THAT THE CONTAINER AND CLOSURE   |
| STERILIZATION SYSTEMS\                                                |
| AND THE PRODUCT FILLING AND CLOSING SYSTEMS ARE BROUGHT TO A          |
| CONDITION OF COMMERCIAL STERILITY BEFORE PACKAGING OPERATIONS BEGIN?  |
| -- 113.40(g)(2)(ii(a) Yes No                                          |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 88\. ARE THE CONTAINER AND CLOSURE STERILIZATION SYSTEMS AND PRODUCT  |
| FILLING AND CLOSING\                                                  |
| SYSTEMS INSTRUMENTED TO DEMONSTRATE THAT THE REQUIRED STERILIZATION   |
| IS BEING\                                                             |
| ACCOMPLISHED CONTINUOUSLY? 113(g)(2)(i)(a) Yes No                     |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 89\. ARE AUTOMATIC RECORDING DEVICES USED TO RECORD THE STERILIZATION |
| MEDIA FLOW RATES, TEMPERATURE, CONCENTRATION OR OTHER FACTORS?        |
| 113.40(g)(2)(i)(a) Yes No N/A                                         |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***LOSS OF STERILITY -- 113.40(2)(ii)(b)***                           |
+-----------------------------------------------------------------------+
| 90\. IS THERE A SYSTEM THAT STOPS PACKAGING OPERATIONS OR             |
| ALTERNATIVELY SEGREGATES ANY\                                         |
| PRODUCT PACKAGED WHEN PACKAGING CONDITONS FALL BELOW SCHEDULED        |
| PROCESSES?\                                                           |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 91\. IN THE EVENT THAT STERILITY IS LOST IN THE PACKAGING SYSTEM, IS  |
| THE SYSTEM RETURNED TO A CONDITION OF COMMERCIAL STERILITY PRIOR TO   |
| RESUMING PACKAGING? Yes No                                            |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***RECORDS -- 113.40(g)(2)(ii)(c)***                                  |
+-----------------------------------------------------------------------+
| 92\. ARE OBSERVATIONS AND MEASUREMENTS OF OPERATING CONDITIONS MADE   |
| AND RECORDED AT\                                                      |
| INTERVALS OF SUFFICIENT FREQUENCY TO ENSURE THAT COMMERCIAL STERILITY |
| OF THE FOOD\                                                          |
| PRODUCT IS BEING ACHIEVED INCLUDING RECORDS OF:                       |
|                                                                       |
| STERILIZATION MEDIA FLOW RATES Yes No N/A                             |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| TEMPERATURES Yes No N/A                                               |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| CONTAINER AND CLOSURE FLOW RATES Yes No N/A                           |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
|                                                                       |
| STERILIZATION CONDITIONS FOR BATCH SYSTEMS Yes No N/A                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***METAL CONTAINERS AND LIDS***                                       |
+-----------------------------------------------------------------------+
| 93\. WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE FIRM? |
|                                                                       |
| *(FOR EXAMPLE, METAL CONTAINERS AND CLOSURES STERILIZED WITH          |
| SUPERHEATED STEAM, FILLED & SEALED IN AN ASEPTIC CHAMBER)*            |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 94\. DOES THE FIRM FOLLOW THEIR FILED SCHEDULED PROCESS FOR BRINGING  |
| THE CONTAINER & LID STERILIZATION EQUIPMENT TO A CONDITION OF         |
| COMMERCIAL STERILITY? Yes No                                          |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 95\. DETERMINE & DOCUMENT THE NUMBER AND TYPE OF TEMPERATURE          |
| MONITORING SENSORS USED TO DEMONSTRATE THAT THE REQUIRED              |
| STERILIZATION IS ACCOMPLISHED:                                        |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 96\. ARE THESE THERMOCOUPLE SENSORS LOCATED IN THE MOST DIFFICULT TO  |
| STERILIZE AREA?\                                                      |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 97\. IS THE POSITION OF THE TEMPERATURE SENSORS AND EQUIPMENT THE     |
| SAME AS FILED WITH FDA?\                                              |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 98\. LIST THE CRITICAL FACTORS BEING MONITORED DURING THE             |
| STERILIZATION OF CONTAINERS, LIDS, FILLING AND CLOSING EQUIPMENT      |
| (E.G. TEMPERATURE, STERILIZATION MEDIA FLOW RATE, ETC):               |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 99\. IS THE MONITORING DATA FOR THESE CRITICAL FACTORS CONTINUOUSLY & |
| ACCURATELY RECORDED?\                                                 |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 100\. DO INDICATING THERMOMETERS AGREE WITH RECORDING THERMOMETERS?   |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 101\. ARE TEMPERATURE INDICATING AND RECORDING DEVICES (TIDS)         |
| PROPERLY CALIBRATED?\                                                 |
| Yes No                                                                |
|                                                                       |
| > IF YES, WHAT IS THE CALIBRATION METHOD AND FREQUENCY?               |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| 102\. IS TID CALIBRATION ACCOMPLISHED AT PROCESSING TEMPERATURE? Yes  |
| No                                                                    |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 103\. IF COLD STERILE WATER IS DIRECTED AGAINST THE BOTTOM OF         |
| CONTAINERS AFTER FILLING (OR ONTO\                                    |
| THE LIDS PRIOR TO CLOSING), WHAT ARE THE FIRM'S CONTROLS TO ENSURE    |
| STERILITY OF THE WATER ON\                                            |
| A CONTINUAL BASIS?                                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 104\. DESCRIBE THE FIRM'S CONTROLS FOR ENSURING THE PROPER RESIDENCE  |
| TIME OF THE CONTAINERS\                                               |
| AND LIDS IN THE STERILIZING MEDIUM:\                                  |
| \                                                                     |
| *(EXAMPLE -- CONTAINERS/CLOSURE FLOW RATE CHECKED WITH A CALIBRATED   |
| STOP WATCH)*                                                          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 105\. WHAT IS THE METHOD AND FREQUENCY FOR TIMING DEVICE CALIBRATION? |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 106\. WHAT IS THE METHOD OF PREVENTING UNAUTHORIZED CHANGES IN        |
| CONTAINER/LID FLOW RATE DURING STERILIZATION?                         |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 107\. IF AN AUTOMATIC DEVICE IS USED TO MONITOR CONTAINER/CLOSURE     |
| FLOW RATES, HOW DOES THE FIRM ASSURE THE ACCURACY OF THESE DEVICES?   |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 108\. HOW DOES THE FIRM ASSURE THAT CONTAINERS AND CLOSURES ARE CLEAN |
| AND DRY PRIOR TO\                                                     |
| ENTERING THE STEAM CHAMBERS?                                          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| ***GLASS, PLASTIC AND PAPERBOARD CONTAINERS***                        |
+-----------------------------------------------------------------------+
| 109\. WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE      |
| FIRM?\                                                                |
| \                                                                     |
| *(FOR EXAMPLE, TETRAPAK PAPERBOARD FORM/FILL/SEAL USING HYDROGEN      |
| PEROXIDE AND HEAT AS STERILANTS;\                                     |
| PRE-FORMED MULTI-LAYERED PLASTIC CUPS STERILIZED, FILLED & SEALED IN  |
| AN ASEPTIC CHAMBER USING HYDROGEN PEROXIDE AND HEAT AS STERILANTS. ;  |
| GLASS BOTTLES FILLED & SEALED IN AN ASEPTIC CHAMBER USING STEAM AS A  |
| STERILANT; PLASTIC CUPS BLOW MOLDED/FILLED, SEALED AND STERILIZED IN  |
| THE MOLD. INCLUDE THE MANUFACTURER AND MODEL NO. OF THE ASEPTIC       |
| FILLING MACHINE.)*                                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 110\. HOW IS HEAT APPLIED FOR CONTAINER STERILIZATION?                |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 111\. DESCRIBE THE FIRM'S PROCEDURE FOR MONITORING ALL CRITICAL       |
| FACTORS FOR THE SCHEDULED PROCESS:                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 112\. ARE SENSORS FOR MONITORING THE ABOVE CRITICAL FACTORS PROPERLY  |
| LOCATED TO PROVIDE ASSURANCE THAT THE FACTORS ARE MONITORED AT THEIR  |
| COLDEST OR WEAKEST POINT?                                             |
|                                                                       |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 113\. IF CHEMICAL STERILANTS ARE SPRAYED IN ASEPTIC CHAMBERS, ARE     |
| SPRAY VOLUMES CONTROLLED BY                                           |
|                                                                       |
| Nozzles Peristaltic Pumps                                             |
|                                                                       |
| Other [     ]{.underline}                                             |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 114\. WHAT IS THE FIRM'S PROCEDURE FOR ASSURING THE USE OF PACKAGING  |
| MATERIALS OF HIGH MICROBIOLOGICAL QUALITY?                            |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 115\. IS THE FILLING/ PACKAGING MACHINES DESIGNED TO AUTOMATICALLY    |
| SHUT DOWN IN THE EVENT OF A FAILURE TO MEET SPECIFIED CRITICAL        |
| FACTORS? Yes No                                                       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 116\. WHO CHECKS THE AUTOMATIC CONTROLS AND HOW FREQUENTLY?           |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 117\. HOW DOES THE FIRM CHALLENGE THE AUTOMATIC CONTROL SYSTEM?       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 118\. UNDER WHAT CIRCUMSTANCES WOULD AN AUTOMATIC MACHINE BE OPERATED |
| IN A MANUAL MODE TO PACK PRODUCT AND WHO WOULD HAVE THE AUTHORITY TO  |
| APPROVE THIS?                                                         |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 119\. ARE THERE ANY MANUAL CONTROLS THAT ARE CRITICAL TO THE          |
| SCHEDULED PROCESS?                                                    |
|                                                                       |
| Yes No                                                                |
|                                                                       |
| IF SO, HOW WOULD A PROCESS DEVIATION BE DETECTED AND HANDLED BY THE   |
| FIRM?                                                                 |
|                                                                       |
| >                                                                     |
| >                                                                     |
| > OTHER COMMENTS:                                                     |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| 120\. DESCRIBE THE FIRM'S PROCEDURE FOR TESTING HYDROGEN PEROXIDE     |
| RESIDUAL ON PACKAGING MATERIAL:                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 121\. IS THE HYDROGEN PEROXIDE RESIDUAL LEVEL (FROM RECORD REVIEW) IN |
| COMPLIANCE WITH PART 178.1005(D)? Yes No                              |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **THERMOFORM-FILLED-SEALED PLASTIC CONTAINERS PRE-STERILIZED BY HEAT  |
| OR CO-EXTRUSION:**                                                    |
+-----------------------------------------------------------------------+
| 122\. WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE      |
| FIRM?                                                                 |
|                                                                       |
| *(FOR EXAMPLE, MULTI-LAYERED PLASTIC WEB IS DIPPED IN HYDROGEN        |
| PEROXIDE BATH AND THEN HEATED AND\                                    |
| FORMED INTO CUPS/FILLED/SEALED WITH FLEXIBLE LIDSTOCK IN AN ASEPTIC   |
| CHAMBER---BOTH BODY AND LID\                                          |
| STERILIZED BY HYDROGEN PEROXIDE AND HEAT BEFORE FILLING.) INCLUDE     |
| MANUFACTURER AND MODEL NO. OF\                                        |
| ASEPTIC FILLING MACHINE.*                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| 123\. DESCRIBE THE FIRM'S PROCEDURES FOR MONITORING ALL FACTORS       |
| CRITICAL TO THE SCHEDULED PROCESS.                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 124\. FOR STERILE AIR THAT PROVIDES OVERRIDING AIR PRESSURE DURING    |
| PROCESSING OPERATIONS, HOW OFTEN ARE THE AIR FILTERS CHANGED AND DOES |
| THIS FREQUENCY COMPLY WITH THE FREQUENCY DELINEATED IN THE SCHEDULED  |
| PROCESS? Yes No                                                       |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 125\. IS THE CHANGE OF AIR FILTERS DOCUMENTED? Yes No                 |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 126\. FOR MULTI-LAYERED CONTAINER BODIES AND LID STOCK DURING F/F/S   |
| OPERATIONS WHERE THE\                                                 |
| OUTER LAYER IS STRIPPED AWAY TO EXPOSE AN INNER STERILE LAYER, HOW    |
| DOES THE FIRM ENSURE PROTECTION OF THE STERILE INNER LAYER AS THE     |
| PACKAGING MATERIAL IS RECEIVED AND USED?                              |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 127\. DESCRIBE THE FIRM'S PROCEDURE FOR ENSURING THAT EQUIPMENT IS    |
| BROUGHT TO A CONDITION OF COMMERCIAL STERILITY AND THAT EXPOSURE OF   |
| THE STERILE INNER LAYER TO THE STERILE ZONE AT\                       |
| THE BEGINNING OF THE PRE-STERILIZATION CYCLE IS PERFORMED IN SUCH A   |
| MANNER AS TO MAINTAIN\                                                |
| THE STERILITY OF BOTH THE PACKAGING MATERIAL AND THE STERILE          |
| PACKAGING AREA:                                                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 128\. DESCRIBE THE PACKAGING SYSTEM INCLUDING MANUFACTURER, MODEL     |
| NO., OPERATION OF THE\                                                |
| FITMENT, THE MEDIA USED TO STERILIZE THE FITMENT AND HOW THE          |
| STERILIZATION PROCESS AND ALL CRITICAL FACTORS SPECIFIED IN THE       |
| SCHEDULED PROCESS ARE CONTROLLED AND MONITORED:                       |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 129\. HOW IS THE MULTI-LAYERED PLASTIC CONTAINER STERILIZED?          |
|                                                                       |
| *(FOR EXAMPLE, THE BAG IS PRE-STERILIZED FOR THE SUPPLIER BY AN       |
| OUTSIDE CONTRACTOR USING GAMMA\                                       |
| RADIATION.)*                                                          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 130\. HOW DOES THE FIRM ASSURE THAT STERILE PACKAGING MATERIALS ARE   |
| RECEIVED AND MAINTAINED STERILE?                                      |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 131\. IF CHEMICALS ARE USED TO STERILIZE THE FITMENT, HOW IS THE      |
| CHEMICAL CONCENTRATION\                                               |
| MONITORED?                                                            |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 132\. DESCRIBE THE FIRM'S PROCEDURE FOR ENSURING THAT EQUIPMENT IS    |
| BROUGHT TO A CONDITION OF COMMERCIAL STERILITY PRIOR TO THE START OF  |
| FILLING:                                                              |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **INCUBATION -- 113.40 (3)**                                          |
+-----------------------------------------------------------------------+
| 133\. EXPLAIN THE INCUBATION PROCEDURES USED BY THE FIRM, INCLUDING   |
| THE NUMBER OF SAMPLES, INCUBATION TIME AND TEMPERATURES, AND THE      |
| FOLLOW UP PROCEDURES FOR ANY POSITIVE RESULTS:                        |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **PROCESS DEVIATIONS -- PART 113.89**                                 |
+-----------------------------------------------------------------------+
| 134\. ARE PROCESS DEVIATIONS MAINTAINED IN A SEPARATE FILE OR LOG?    |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 135\. REVIEW RECORDS DOCUMENTING PROCESS DEVIATIONS (INCLUDING        |
| PROCESS DEVIATION FILE)                                               |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 136\. WHAT IS THE FIRM'S PROCEDURES FOR HANDLING PROCESS DEVIATIONS?  |
|                                                                       |
| *(FOR EXAMPLE, A DROP IN PRODUCT TEMPERATURE IN THE HOLDING TUBE OR   |
| OF DIFFERENTIAL PREESSURE IN THE PRODUCT TO PRODUCT REGENERATOR BELOW |
| SPECIFIED LIMITS.)*                                                   |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 137\. WERE ALL PROCESS DEVIATIONS HANDLED IN ACCORDANCE WITH THE      |
| FIRM'S PROCEDURES AND PART 113.89? Yes No                             |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **CONTAINER CLOSURE EVALUATION -- Part 113.60(a)(1) & (3)**           |
+-----------------------------------------------------------------------+
| 138\. DO THE FIRM'S CONTAINER INTEGRITY EVALUATION PROCEDURES COMPLY  |
| WITH THE VISUAL AND TEARDOWN REQUIREMENTS OF PART 113.60(a)(1) & (3)? |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 139\. DESCRIBE THE FIRM'S CONTAINERS AND THEIR PROCEDURES FOR         |
| ENSURING CONTAINER INTEGRITY:                                         |
|                                                                       |
| *(INCLUDE THE FIRM'S HANDLING, SAMPLING & TESTING OF INCOMING         |
| CONTAINERS AND PACKAGING MATERIALS, AND THEIR VISUAL AND TEARDOWN     |
| TEST PROCEDURES FOR FINISHED PRODUCT CONTAINERS TO ASSURE CONTAINER   |
| INTEGRITY.)*                                                          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| **POST-PROCESS CONTAINER HANDLING**                                   |
+-----------------------------------------------------------------------+
| 140\. ARE CONTAINERS PROPERLY HANDLED DURING THEIR CONVEYANCE FROM    |
| FILLING AND PROCESSING AREAS OF THE PLANT TO WAREHOUSE LABELING AND   |
| STORAGE AREAS TO ASSURE MAINTENANCE OF PACKAGE AND SEAL INTEGRITY?    |
| Yes No                                                                |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 141\. DESCRIBE THE FIRM'S POST-PROCESS HANDLING PROCEDURES:           |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **TRAINING -- Part 113.10**                                           |
+-----------------------------------------------------------------------+
| 142\. HAS THE FIRM MET THE REQUIREMENTS OF PART 113.10 FOR ATTENDANCE |
| AT BETTER PROCESS CONTROL SCHOOL? Yes No                              |
|                                                                       |
| COMMENTS:                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| 143\. DESCRIBE THE FIRM'S TRAINING PROGRAM FOR OPERATORS OF PRODUCT   |
| AND PACKAGE STERILIZATION SYSTEMS:                                    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+