Spreadsheet: 100550d1298907340-counting-data-that-meets-two-criteria-in-excel2003-book1
Sheet: Sheet1

Record ID | Assigned To | Attachment | Area | Classification | Category | Comments | Completed By | Completed On | Cost Center Code / Name | Date Created | Date Current State | Date Opened | Description | Due Date | Effectiveness Review Comments | Effectiveness Review Date Due | Effectiveness Review QA | Effectiveness Review Required? | Acknowledged by | Acknowledged on | Action Attachment | All Children Closed By | All Children Closed On | [NAME] | Approved Action Plan by | Approved Action Plan on | Approved By | Approved On | Approved to Release by | Approved to Release on | Area Manager [NAME] | Category (Not in Use) | Closed by | Closed on | Customer | Date Closed | Date of Occurrence | Detectability | Disposition / Impact | Due Date Extension | [NAME] | Duplicate ID | Entity | Equipment | Final Disposition | Final Justification | Full Permission | Genzyme Number | Immediate Actions Taken | Investigation Details | MFG Pro Code | Management Approver | Occurrence | Originator | Parent ID | Planned / Un-Planned | Priority | Process | Propose Action Plan by | Propose Action Plan on | QA Approved By | QA Approved On | QA Reviewer | RPN | Reason Opened | Record Type | Rejected Submission By | Rejected Submission On | Rejected By | Rejected On | Related Document Number | Related Records | Require Area Manager Feedback? | Results | QA Reviewed By | QA Reviewed On | Reviewer | Risk | Risk Assessment | Risk Level | Root Cause Completed By | Root Cause Completed On | Severity | Severity Type | Short Description | Site | Site Code | Source ID | [NAME]. Number | Start Date | [NAME] | Submitted By | Submitted On
46035 | Posada, [NAME] |  | F-Mfg Support |  | Management and periodic process reviews | 19Jan11: QA Comment: In response to the EMA audit of Allston in November 2010, this preventative action was required. The program for validating the clean hold time will be implemented by adopting the corporate standard. All corporate standards are to be |  |  | USAGBX4700:Quality Assurance | 2011-01-18 13:12:00 | 2011-01-18 13:14:00 |  | In response to a GRT review, a validation will be performed to establish the Clean Hold Time for reusable materials after washing and prior to sterilization. A risk assessment will be performed to identify any additional critical materials. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-037 |  |  |  |  |  | [NAME], [NAME] | 45374 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  | EQ2-090 |  |  |  |  |  |  |  |  |  |  |  |  |  | Validate Clean Hold Times for reusable materials prior to sterilization. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-01-18 13:14:00
43906 | [NAME], [NAME] |  | B-Engineering |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2010-12-22 10:08:00 | 2010-12-22 10:09:00 |  | Allston FDA 2009 observation text:  There is an observation window, approximately 5 ft (h) x 12 ft (w), in corridor EX2-02 that is used to observe the aseptic filling operations. The window seals and the sections where the window stainless steel frame m | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-028 |  |  |  |  |  | [NAME], [NAME] | 43182 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | GRT: No installation qualification for cleanroom windows | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-22 10:09:00
43903 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews | This is a long lead item which involves deployment of a validated asset management system and SOP's which govern the analysis, risk assessment, and criteria for asset criticality.  Conforming to the standard in full will close this gap.  After review of |  |  | USAGBX4990:Facilities | 2010-12-22 09:35:00 | 2010-12-22 09:36:00 |  | Allston FDA inspection 2009 response:  Critical instruments must be identified and calibrated; control of instruments on critical pieces of equipment is required.  SOP governing assessment of asset criiticality, status, identification, and cal requireme | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-027 |  |  |  |  |  | [NAME], [NAME] | 43179 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Write SOP to conform to Corp Standard on Maintenance of Facilities and Equipment requirement | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-22 09:36:00
42717 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 10Dec10: Sidney Street does not do a [NAME]. [NAME] is moving to this as part of annual requalification in accordance with the corporate standard. The Sterilization and Depyrogenation standard remediation plan is pending. All corporate sta |  |  | USAGBX4700:Quality Assurance | 2010-12-10 13:11:00 | 2010-12-10 13:12:00 |  | Comply with corporate validation guidelines on sterilization control and validation, to include implementation of air removal verifications. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-016 |  |  |  |  |  | [NAME], [NAME] | 41101 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Implementation of air removal verifications per Corporate standards | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-10 13:12:00
42686 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 10Dec10: Sidney Street does not do [NAME]. [NAME] is moving to this as part of the annual requalfication in accordance with the corporate standard. At this time, the [NAME] and Depyrogenation standard remediation plan is pending. Al |  |  | USAGBX4700:Quality Assurance | 2010-12-10 11:32:00 | 2010-12-10 11:33:00 |  | Comply with corporate validation guidelines on sterilizer and oven equilibration and uniformity criteria. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-015 |  |  |  |  |  | [NAME], [NAME] | 41100 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Comply with corporate validation guidelines on sterilizer and oven equilibration and uniformity criteria. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-10 11:33:00
42326 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the Lyon CQC audit in 2010, this preventative action was required. Sidney Street will implement the corporate standard for cleaning validation. The new procedure will ensure to include controls, worst case conditions and rinse volu |  |  | USAGBX4700:Quality Assurance | 2010-12-07 08:58:00 | 2010-12-07 08:59:00 |  | Comply with corporate standard on cleaning validation. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-012 |  |  |  |  |  | [NAME], [NAME] | 41103 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Comply with corporate standard on cleaning validation | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-07 08:59:00
42325 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: As a result of the CQC audit of Lyon in 2010, this preventative action was required. As part of the implementation of the  Process Validation standard, this CAPA will ensure that there is a requirement to perform a critical review or appropri |  |  | USAGBX4700:Quality Assurance | 2010-12-07 08:48:00 | 2010-12-07 08:49:00 |  | Comply with corporate standard on process validation. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-011 |  |  |  |  |  | [NAME], [NAME] | 41102 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Ensure a review of process validation results by implementing the Process Validation standard. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-07 08:49:00
41461 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2010-11-29 08:19:00 | 2010-11-29 08:20:00 |  | Comply with corporate standards on both Aseptic Process Validation and Environmental Control | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-11-060 |  |  |  |  |  | [NAME], [NAME] | 41104 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Comply with corporate standards on both Aseptic Process Validation and Environmental Control | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-11-29 08:20:00
41434 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2010-11-28 19:29:00 | 2010-11-28 19:30:00 |  | Review the EU requirements and identify any critical and urgent gaps to remediate.  Other compliance gaps will be addressed during the adoption of the corporate standard on Laboratory Equipment  and Lifecycle Management of Computer Systems | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-11-059 |  |  |  |  |  | [NAME], [NAME] | 41094 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Comply with corporate standards on both Laboratory Equipment Qualification and Lifecycle Management of Computer Systems | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-11-28 19:30:00
48265 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2011-02-11 09:36:00 | 2011-02-11 11:34:00 | 2011-02-11 09:36:00 | The Sidney Street facility must comply with the corporate standard for cold chain validation. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2011-02-11 11:34:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-018 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2011-02-11 09:38:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Comply with Corporate Standard on Cold Chain Validation | Sidney Street | [NAME] |  | N/A |  | Pending QA Approval | [NAME], [NAME] | 2011-02-11 09:36:00
48263 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2011-02-11 09:28:00 | 2011-02-11 11:30:00 | 2011-02-11 09:28:00 | Sidney Street must comply with the corporate standard for cleaning validation.  If swabbing is used as a test method at 64SS, a documented rationale for what constitutes worst-case swabbing locations must be included. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2011-02-11 11:30:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-017 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2011-02-11 09:33:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Comply with Corporate Standard for Cleaning Validation | Sidney Street | [NAME] |  | N/A |  | Pending QA Approval | [NAME], [NAME] | 2011-02-11 09:30:00
45374 | Posada, [NAME] |  | F-Mfg Support |  | Management and periodic process reviews | 19Jan11: QA Comment: In response to the EMA audit of Allston in November 2010, this preventative action was required. The program for validating the clean hold time will be implemented by adopting the corporate standard. All corporate standards are to be |  |  | USAGBX4700:Quality Assurance | 2011-01-10 23:07:00 | 2011-01-18 13:12:00 | 2011-01-10 23:07:00 | In response to a GRT review, a validation will be performed to establish the Clean Hold Time for reusable materials after washing and prior to sterilization. A risk assessment will be performed to identify any additional critical materials. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Tournas, [NAME] | 2011-01-11 08:11:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-011 |  |  |  | Tournas, [NAME] |  | Posada, [NAME] |  |  |  |  | Posada, [NAME] | 2011-01-10 23:27:00 | [NAME], [NAME] | 2011-01-18 13:12:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  | EQ2-090 |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Validate Clean Hold Times for reusable materials prior to sterilization. | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Posada, [NAME] | 2011-01-10 23:12:00
43179 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews | This is a long lead item which involves deployment of a validated asset management system and SOP's which govern the analysis, risk assessment, and criteria for asset criticality.  Conforming to the standard in full will close this gap.  After review of |  |  | USAGBX4990:Facilities | 2010-12-15 15:46:00 | 2010-12-22 09:36:00 | 2010-12-15 15:46:00 | Allston FDA inspection 2009 response:  Critical instruments must be identified and calibrated; control of instruments on critical pieces of equipment is required.  SOP governing assessment of asset criiticality, status, identification, and cal requireme | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-12-15 22:07:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-007 |  |  |  | Entstrasser, [NAME] |  | DiOrio, [NAME] R |  |  |  |  | DiOrio, [NAME] R | 2010-12-15 15:55:00 | [NAME], [NAME] | 2010-12-22 09:36:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Define tracking and identification requirements for critical manufacturing equipment | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | DiOrio, [NAME] R | 2010-12-15 15:52:00
41104 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | QA Comment 29Nov10: In response to the Framingham 2008 FDA audit as well as the Framingham October 2010 FDA audit, smoke studies are required to be performed for ISO Class 5 areas. Implementation of the Aseptic Process Validation as well as the Envioronme |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:34:00 | 2010-11-29 08:26:00 | 2010-11-23 23:34:00 | Comply with corporate standards on both Aseptic Process Validation and Environmental Control | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-26 14:46:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-053 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:08:00 | [NAME], [NAME] | 2010-11-29 08:26:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Perform dynamic airflow visualization ("smoke studies") for ISO 5 areas, and include worst-case conditions | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:35:00
41103 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the Lyon CQC audit in 2010, this preventative action was required. Sidney Street will implement the corporate standard for cleaning validation. The new procedure will ensure to include controls, worst case conditions and rinse volu |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:30:00 | 2010-12-07 08:59:00 | 2010-11-23 23:30:00 | Comply with corporate standard on cleaning validation. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:22:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-052 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:07:00 | [NAME], [NAME] | 2010-12-07 08:59:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Include controls, worst-case conditions, and rinse volumes in cleaning validations | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:31:00
41102 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: As a result of the CQC audit of Lyon in 2010, this preventative action was required. As part of the implementation of the  Process Validation standard, this CAPA will ensure that there is a requirement to perform a critical review or appropri |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:27:00 | 2010-12-07 08:49:00 | 2010-11-23 23:27:00 | Comply with corporate standard on process validation. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:20:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-051 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:07:00 | [NAME], [NAME] | 2010-12-07 08:49:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Perform critical review or appropriate statistical analysis of process validation results | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:28:00
41101 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 10Dec10: Sidney Street does not do a [NAME]. [NAME] is moving to this as part of annual requalification in accordance with the corporate standard. The Sterilization and Depyrogenation standard remediation plan is pending. All corporate sta |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:20:00 | 2010-12-10 13:12:00 | 2010-11-23 23:20:00 | Comply with corporate validation guidelines on sterilization control and validation, to include implementation of air removal verifications. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:21:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-050 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:06:00 | [NAME], [NAME] | 2010-12-10 13:12:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Implement air removal verification for steam sterilization processes | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:21:00
41100 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 10Dec10: Sidney Street does not do [NAME]. [NAME] is moving to this as part of the annual requalfication in accordance with the corporate standard. At this time, the [NAME] and Depyrogenation standard remediation plan is pending. Al |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:17:00 | 2010-12-10 11:33:00 | 2010-11-23 23:17:00 | Comply with corporate validation guidelines on sterilizer and oven equilibration and uniformity criteria. | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:22:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-049 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:06:00 | [NAME], [NAME] | 2010-12-10 11:33:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Assess and address uniformity and equilibration concerns for sterilization | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:18:00
41094 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 28Nov10: Per the MHRA inspection of the [NAME] site on October 6-8, 2009, this preventative action was required to be taken. For task 41434, the due date for completion is scheduled for December 31, 2012. The two standards referenced in the task may be |  |  | USAGBX4700:Quality Assurance | 2010-11-23 22:40:00 | 2010-11-28 19:34:00 | 2010-11-23 22:40:00 | Review the EU requirements and identify any critical and urgent gaps to remediate.  Other compliance gaps will be addressed during the adoption of the corporate standard on Laboratory Equipment Qualification | 2012-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-26 14:52:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-043 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:04:00 | [NAME], [NAME] | 2010-11-28 19:34:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Assess lab equipment and software for EU compliance | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 22:41:00
44351 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | Initiated to track gap remediation tasks.  EBN 29Dec10  QA Comment 26Jan11: As a follow up to CAPA 38732 from the MHRA audit of Allston in 2009, this additional preventative action was required. CAPA 38732 assessed Sidney Street procedures and determine |  |  | USAGBX4800:Quality Control | 2010-12-29 10:45:00 | 2011-01-04 08:35:00 | 2010-12-29 10:45:00 | Incorporate sample expiry periods for QC microbiological test samples in related procedures | 2012-07-17 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-04 08:35:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-022 |  |  |  | [NAME], [NAME] |  | [NAME], [NAME] |  |  |  |  | Prinzi, [NAME] | 2011-01-04 08:17:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  | DR#38732 |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- Incorporate sample expiry periods for QC microbiological test samples | Sidney Street | [NAME] |  | GRT |  | Pending QA Approval | Services, TrackWise | 2010-12-29 10:46:00
47860 | DiOrio, [NAME] R |  | B-Engineering |  | Internal/External audits and inspections |  |  |  | USAGBX4990:Facilities | 2011-02-08 08:19:00 | 2011-02-08 08:19:00 |  | Revise SOP EQ2-086 to clearly indicate responsibility on entering alarm text / acknowledgement.  Make programming changes as required to support the change. | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-011 |  |  |  |  |  | Kaszuba, Michelle S | 47301 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | EQ2-086;QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-01a-d Revise EQ2-086 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Kaszuba, Michelle S | 2011-02-08 08:19:00
44761 | Posada, [NAME] |  | F-Mfg Support |  | Management and periodic process reviews | QA Comment 04Jan11: In response to the FDA inspection of Lyon in October 2010, this preventative action was required. QA approves this preventative action plan. 04Jan11 JPM |  |  | USAGBX4700:Quality Assurance | 2011-01-04 20:31:00 | 2011-01-04 20:32:00 |  | In response to a GRT review, 10X Dispase, Amikacin/Vankomacin, Thermolysin, and Insulin media which are made in-house will need to be evaluated to determine mixing times. A study will be performed to establish the minimum and maximum mixing times for thes | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-010 |  |  |  |  |  | [NAME], [NAME] | 44730 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  | MF5-032;MF5-046;MF5-038;MF5-005 |  |  |  |  |  |  |  |  |  |  |  |  |  | Perform study to establish mixing times for media. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-01-04 20:32:00
38964 | DiOrio, [NAME] R |  | A-Environmental Controls |  | Management and periodic process reviews | Observation Text from MHRA Allston October 2009: 3.8.3  [NAME] airflow units were not alarmed, although an initial check was carried out prior to starting manufacturing activities, no airflow checks were done prior to critical operations such as open ma |  |  | USAGBX4990:Facilities | 2010-11-04 14:40:00 | 2010-11-04 14:41:00 |  | Per 2009 MHRA inspectional observation in ALF, all BSC's should have flow / static pressure alarm to warn operator of malfunction or operating state which is inconsistent with last certification. | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-11-012 |  |  |  |  |  | [NAME], [NAME] | 38241 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Purchase and install all alarm units | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-11-04 14:41:00
16200 | Duguid, E John | C:\Documents and Settings\grama06\Desktop\RI-014-02-01.pdf | MTS |  | Risk assessment |  |  |  |  | 2009-12-21 13:33:00 | 2009-12-21 13:34:00 |  | Mitigation Activities for MACI Rapid Mycoplasma Design FMEA RI-011-02-01.   6.2.10. Provide molecular biology knowledge to all analysts running the test. | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2009-12-051 |  |  |  |  |  | Gray, Marissa A | 15798 |  |  |  |  |  |  |  | Gray, Marissa A |  |  | Task |  |  |  |  | QA1-032 |  |  |  |  |  |  |  |  |  |  |  |  |  | Mitigation Activities for MACI Rapid Mycoplasma Design FMEA RI-011-02-01_6.2.10. Provide molecular biology knowledge | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2009-12-21 13:34:00
16199 | Duguid, E John | C:\Documents and Settings\grama06\Desktop\RI-014-02-01.pdf | MTS |  | Risk assessment |  |  |  |  | 2009-12-21 13:31:00 | 2009-12-21 13:32:00 |  | Mitigation Activities for MACI Rapid Mycoplasma Design FMEA RI-011-02-01.   6.2.9. Review QC Electronic Data SOP; Investigate networking computer and routine raw data backup. | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2009-12-050 |  |  |  |  |  | Gray, Marissa A | 15798 |  |  |  |  |  |  |  | Gray, Marissa A |  |  | Task |  |  |  |  | QA1-032 |  |  |  |  |  |  |  |  |  |  |  |  |  | MACI Rapid Mycoplasma Design FMEA RI-011-02-01_6.2.9. Review QC Electronic Data SOP | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2009-12-21 13:32:00
44730 | Posada, [NAME] |  | F-Mfg Support |  | Management and periodic process reviews | QA Comment 04Jan11: In response to the FDA inspection of Lyon in October 2010, this preventative action was required. QA approves this preventative action plan. 04Jan11 JPM |  |  | USAGBX4700:Quality Assurance | 2011-01-04 14:49:00 | 2011-01-04 20:32:00 | 2011-01-04 14:49:00 | In response to a GRT review, 10X Dispase, Amikacin/Vankomacin, Thermolysin, and Insulin media which are made in-house will need to be evaluated to determine mixing times. A study will be performed to establish the minimum and maximum mixing times for thes | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Tournas, [NAME] | 2011-01-04 16:28:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-005 |  |  |  | Tournas, [NAME] |  | Posada, [NAME] |  |  |  |  | Posada, [NAME] | 2011-01-04 16:22:00 | [NAME], [NAME] | 2011-01-04 20:32:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  | MF5-038;MF5-005;MF5-032;MF5-046 |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Perform study to establish mixing times for media. | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2011-01-04 14:57:00
38241 | DiOrio, [NAME] R |  | A-Environmental Controls |  | Management and periodic process reviews | Observation Text from MHRA Allston October 2009: 3.8.3  [NAME] airflow units were not alarmed, although an initial check was carried out prior to starting manufacturing activities, no airflow checks were done prior to critical operations such as open ma |  |  | USAGBX4990:Facilities | 2010-10-28 11:13:00 | 2010-11-04 14:46:00 | 2010-10-28 11:13:00 | Per 2009 MHRA inspectional observation in ALF, all BSC's should have flow / static pressure alarm to warn operator of malfunction or operating state which is inconsistent with last certification. | 2011-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-03 14:15:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-10-015 |  |  |  | Entstrasser, [NAME] |  | DiOrio, [NAME] R |  |  |  |  | DiOrio, [NAME] R | 2010-10-28 11:20:00 | [NAME], [NAME] | 2010-11-04 14:46:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Add air flow alarm to all BSC's | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | DiOrio, [NAME] R | 2010-10-28 11:14:00
43907 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews |  |  |  | USAGBX4990:Facilities | 2010-12-22 10:10:00 | 2010-12-22 10:11:00 |  | Allston FDA 2009 observation text:  There is an observation window, approximately 5 ft (h) x 12 ft (w), in corridor EX2-02 that is used to observe the aseptic filling operations. The window seals and the sections where the window stainless steel frame m | 2011-12-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-029 |  |  |  |  |  | [NAME], [NAME] | 43182 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Engineering will write addendum to 1996 cleanroom IQ | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-22 10:11:00
43182 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews | In response to the Allston FDA audit from 2009, this preventative action was required. QA approves this preventative action plan. JPM 21Dec10 |  |  | USAGBX4990:Facilities | 2010-12-15 15:58:00 | 2010-12-22 10:21:00 | 2010-12-15 15:58:00 | Allston FDA 2009 observation text:  There is an observation window, approximately 5 ft (h) x 12 ft (w), in corridor EX2-02 that is used to observe the aseptic filling operations. The window seals and the sections where the window stainless steel frame m | 2011-12-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-12-15 22:08:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-008 |  |  |  | Entstrasser, [NAME] |  | DiOrio, [NAME] R |  |  |  |  | DiOrio, [NAME] R | 2010-12-15 16:01:00 | [NAME], [NAME] | 2010-12-22 10:21:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: No installation qualification for cleanroom windows | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | DiOrio, [NAME] R | 2010-12-15 15:59:00
40784 | Rowe, [NAME] |  |  |  | Equipment Failures | Based on this investigation, the following was determined about low C02 levels in incubator # (C-3704-002) between 08/2009 - 08/2010:  1)  The CO2 sensor in question was not operating properly at the time of calibration.  The sensor in question was 4 ye |  |  | USAGBX4700:Quality Assurance | 2010-11-20 03:50:00 | 2010-11-20 03:51:00 | 2010-11-20 03:50:00 | CAPA Description: Release CO2 Incubator (C-3704-001, C-3704-002) following replacement of the CO2 sensor and successful CO2 component calibration.  Deviation Description: Calibration technician observed in room 338 (QC Lab) that the incubator CO2 perc | 2011-11-19 00:00:00 |  | 2011-11-19 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-11-002 |  |  |  |  |  | [NAME], [NAME] | 40381 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | Release CO2 Incubator (C-3704-001, C-3704-002) following repairs | Sidney Street | [NAME] |  |  |  | Pending Area Manager Feedback
44407 | Rowe, [NAME] |  | H-QC Material / Product Release |  | Deviations to manufacturing/testing instructions and SOP's | All 3 root causes are corrected under the 1 action plan  SP 11/21/10 Corrected category type from "equipment failure" to "deviation from testing SOP"  Failing to close the valves was not confirmed as the cause of the autoclave failure.  EBN 30Dec10 |  |  | USAGBX4800:Quality Control | 2010-12-30 03:50:00 | 2010-12-30 03:52:00 | 2010-12-30 03:50:00 | CAPA Description: QC5-004 will be revised to include closing the sampling valve.  In addition, an evaluation of the sampling process will be performed.  Deviation Description: The Manufacturing Autoclave Vacuum System failed after the Steam Sample Val | 2011-10-05 00:00:00 |  | 2011-04-30 00:00:00 | Sellers, Amanda M | Yes |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-12-004 |  |  |  |  |  | Sellers, Amanda M | 40696 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | Revision of QC5-004 and evaluation of sampling process for steam sampling | Sidney Street | [NAME] |  |  |  | Pending Area Manager Feedback
42305 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the MHRA inspection of the Allston facility in October 2009, this preventative action was required.  [NAME] stret will adopt the Sterilization and Depyrogentation standard in order to complete this CAPA. QA approves this preventati |  |  | USAGBX4700:Quality Assurance | 2010-12-07 08:06:00 | 2010-12-07 08:07:00 |  | Verify that when [NAME] test kits are implemented at Sidney Street in concert with adoption of the corporate standard, they are stored in conditions compliant with the manufacturer’s recommendations. | 2011-09-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-009 |  |  |  |  |  | [NAME], [NAME] | 41099 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Verify proper storage of [NAME] test kits per MFG instructions | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-07 08:07:00
41099 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the MHRA inspection of the Allston facility in October 2009, this preventative action was required.  [NAME] stret will adopt the Sterilization and Depyrogentation standard in order to complete this CAPA. QA approves this preventati |  |  | USAGBX4700:Quality Assurance | 2010-11-23 23:00:00 | 2010-12-07 08:06:00 | 2010-11-23 23:00:00 | Verify that when [NAME] test kits are implemented at Sidney Street in concert with adoption of the corporate standard, they are stored in conditions compliant with the manufacturer’s recommendations. | 2011-09-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:23:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-048 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:05:00 | [NAME], [NAME] | 2010-12-07 08:06:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Verify proper storage of [NAME] test kits once implemented | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 23:01:00
47922 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 12:25:00 | 2011-02-08 12:25:00 |  | Clean / replace flooring where stain exists in Room 276 | 2011-09-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-033 |  |  |  |  |  | Kaszuba, Michelle S | 47315 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-06b Room 276 repair | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 12:25:00
47921 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 12:22:00 | 2011-02-08 12:23:00 |  | Replace / repair flooring at coving in Rooms 275 / 276 | 2011-09-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-032 |  |  |  |  |  | Kaszuba, Michelle S | 47315 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-06a Repairs to coving Rm 275 / 276 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 12:23:00
41108 | Prinzi, [NAME] |  |  |  |  | Due date extended, see attached approval email MSK 10/19/09   Due date extension requested for March 5th. JW 19 FEB 2010   Root Cause: The charcoal component in the media is responsible for inactivating antibiotics. The Scotland charcoal (CGSP) did n |  |  | USAGBX4800:Quality Control | 2010-11-24 03:54:00 | 2010-11-24 04:02:00 | 2010-11-24 03:54:00 | CAPAs:  1. Quality agreement with bioMérieux (# 09-03) issued on December 18, 2009 to ensure any changes to the BacT/ALERT Rapid System will be communicated to Genzyme. (Completed and will not be added as Task)  2. Validation of a new 1mL testing samp | 2011-08-31 00:00:00 |  | 2011-04-29 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-11-003 |  |  |  |  |  | [NAME], [NAME] | 19734 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | CAPAs issued for BacT/Alert Charcoal Event | Sidney Street | [NAME] |  |  |  | Pending QA Approval
45683 | Rowe, [NAME] |  | H-QC Material / Product Release |  | Management and periodic process reviews |  |  |  | USAGBX4800:Quality Control | 2011-01-13 15:33:00 | 2011-01-17 10:30:00 |  | Note:  Revise or create a procedure describing labeling and expiry dating requirements for Class 1 disposable materials in QC.  This revision is been done due to recurrent internal audit findings, and a recent management walk-through IAW QA1-041 JCG 13 J | 2011-07-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-029 |  |  |  |  |  | [NAME], [NAME] | 44449 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task | Rowe, [NAME] | 2011-01-14 16:55:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Revise [NAME] describing labeling and expiry dating requirements for Class 1 disposable materials in QC. | Sidney Street | [NAME] |  | Management Walk-through# SP-10-QC-12 |  | Work in Progress | Rowe, [NAME] | 2011-01-17 10:30:00
44869 | [NAME], [NAME] |  | B-Engineering |  | Equipment Failures | Recommend opening two CAPA records.  CAPA for equipment release assigned to Validation.  Equipment can be used once Validation CAPA record closes.  NLD 11/01/10 |  |  | USAGBX4815:BioSurgery | 2011-01-05 16:16:00 | 2011-01-05 16:17:00 |  | CAPA Description: Revise SOPs for Refrigerator and Freezer PM and Incubator PM to include changing batteries on chart recorders every 6 mo  Deviation Description: Refrigerator C-3709 went out of spec. Refrigerator C-3709 was found during daily metrol | 2011-07-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-021 |  |  |  |  |  | [NAME], [NAME] | 40813 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  | MF1-010 |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], PM of Refrigerators and Freezers, to require changing the chart recorder batteries twice per year. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-01-05 16:17:00
44868 | [NAME], [NAME] |  | B-Engineering |  | Equipment Failures | Recommend opening two CAPA records.  CAPA for equipment release assigned to Validation.  Equipment can be used once Validation CAPA record closes.  NLD 11/01/10 |  |  | USAGBX4815:BioSurgery | 2011-01-05 16:14:00 | 2011-01-05 16:15:00 |  | CAPA Description: Revise SOPs for Refrigerator and Freezer PM and Incubator PM to include changing batteries on chart recorders every 6 mo  Deviation Description: Refrigerator C-3709 went out of spec. Refrigerator C-3709 was found during daily metrol | 2011-07-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-020 |  |  |  |  |  | [NAME], [NAME] | 40813 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  | MF1-010 |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], PM of Incubators, to require changing the chart recorder batteries twice per year. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-01-05 16:15:00
40813 | Dulac, [NAME] |  | B-Engineering |  | Equipment Failures | Recommend opening two CAPA records.  CAPA for equipment release assigned to Validation.  Equipment can be used once Validation CAPA record closes.  NLD 11/01/10 |  |  | USAGBX4815:BioSurgery | 2010-11-21 12:22:00 | 2011-01-05 16:17:00 | 2010-11-21 12:22:00 | Refrigerator C-3709 went out of spec. Refrigerator C-3709 was found during daily metrology to have no LED display reading, with the chart recorder reading 11 C.  Chart recorder was stopped at 4:00. | 2011-07-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | DiOrio, [NAME] R | 2011-01-05 16:11:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-034 | All materials were moved to alternate storage. 'Do not use' sign was placed on the refrigerator and the 'out of limits' was initiated. |  |  | DiOrio, [NAME] R |  | Pai, [NAME] | 34265 |  |  |  | Dulac, [NAME] | 2011-01-05 15:54:00 | [NAME], [NAME] | 2011-01-05 16:17:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  | MF1-010 |  | No |  |  |  |  |  |  |  |  |  |  |  | Revise SOPs for Refrigerator and Freezer PM and Incubator PM to include changing batteries on chart recorders every 6 mo | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-21 12:23:00
47950 | Tournas, [NAME] |  | I-QADC |  | Management and periodic process reviews | QA comment 08Feb11: In response to the EMA inspection of Framingham in 2010, this preventative action was required. QA approves this preventative action plan. JPM 08Feb11 |  |  | USAGBX4815:BioSurgery | 2011-02-08 19:33:00 | 2011-02-08 19:34:00 |  | Revise material specifications for critical media, solutions, and enzymes to include the manufacturer's site address. | 2011-07-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-036 |  |  |  |  |  | [NAME], [NAME] | 46851 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Revise M/Ss of critical solutions, enzymes, & Media to include addresses of qualified manufacturers | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 19:34:00
46851 | Tournas, [NAME] |  | I-QADC |  | Management and periodic process reviews | QA comment 08Feb11: In response to the EMA inspection of Framingham in 2010, this preventative action was required. QA approves this preventative action plan. JPM 08Feb11 |  |  | USAGBX4815:BioSurgery | 2011-01-27 15:53:00 | 2011-02-08 19:33:00 | 2011-01-27 15:53:00 | Revise material specifications for critical media, solutions, and enzymes to include the manufacturer's site address. | 2011-07-29 00:00:00 |  |  |  |  |  |  |  |  |  |  | Ernesti, [NAME] | 2011-02-07 14:16:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-019 |  |  |  | Ernesti, [NAME] |  | Tournas, [NAME] |  |  |  |  | Tournas, [NAME] | 2011-02-04 14:33:00 | [NAME], [NAME] | 2011-02-08 19:33:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT-2.1.2 Add Manufacturers' address to M/S | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2011-01-27 15:54:00
48452 | [NAME], [NAME] |  | G-QC Micro |  | Management and periodic process reviews |  |  |  | USAGBX4800:Quality Control | 2011-02-14 13:56:00 | 2011-02-14 14:03:00 | 2011-02-14 13:56:00 | GRT- Revise QC2-012 to incorporate the requirement to perform pre-use weight checks on QC tabletop balances. | 2011-07-28 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-022 |  |  |  | [NAME], [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2011-02-14 14:03:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- Revise QC2-012 to incorporate pre-use weight checks on QC tabletop balances | Sidney Street | [NAME] |  | [NAME] Obs. 3.7 |  | Pending Action Plan Approval | Services, TrackWise | 2011-02-14 13:58:00
47924 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 12:31:00 | 2011-02-08 12:34:00 |  | d) Install baseboard in Irradiator Room e) Repair chair rail and conceal / remove screw penetrating chair rail in Irradiator Room f) Repair wall and remove tape in Irradiator Room | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-035 |  |  |  |  |  | Kaszuba, Michelle S | 47315 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-06 d, e & f  Irradiator Room Repair | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 12:34:00
47923 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 12:28:00 | 2011-02-08 12:29:00 |  | Relieve room pressure or secure HEPA in Carticel Gown Out | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-034 |  |  |  |  |  | Kaszuba, Michelle S | 47315 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-06c Carticel Gown Out | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 12:29:00
47885 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Also, replace reference to EQ1-006 to QA3-002.  Move sentence to after alert level list for readability.  Reassigned to [NAME] RRD 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 09:47:00 | 2011-02-08 09:48:00 |  | Revise section EQ2-039 7.6 to clarify the fact that these are alert levels, not specifications. | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-027 |  |  |  |  |  | Kaszuba, Michelle S | 47328 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008;EQ2-039 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-10a Revise EQ2-039 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 09:48:00
47870 | [NAME], [NAME] R |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 08:46:00 | 2011-02-08 08:47:00 |  | Revise SOP MF7-002.  Add data sheet to record actions and equipment data. | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-020 |  |  |  |  |  | Kaszuba, Michelle S | 47319 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | QA1-008;MF7-002 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-08 a & b Revise MF7-002 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 08:47:00
42312 | Ernesti, [NAME] |  | I-QADC |  | Deviations to cGMP/Quality System Requirements/Regulatory Filings | 07Dec10: In response to the MHRA inspection of Allston in October 2009, this preventative action was required. Sidney Street will adopt the Maintenance of Facilities and Equipment standard to address this audit observation. QA approves this preventative a | Ernesti, [NAME] | 2010-12-07 09:27:00 | USAGBX4810:MFG Management | 2010-12-07 08:24:00 | 2010-12-22 10:37:00 |  | Allston 2009 GRT observation for appropriate manufacturing shutdown times for critical maintenance and facility upgrades or improvements. | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-010 |  |  |  |  |  | [NAME], [NAME] | 41231 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  | [NAME], [NAME] | 2010-12-22 10:37:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Sindey Street will follow the standard for Maintenance of Facilities and Equipment with respect to facility maintenance | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-07 08:25:00
48317 | DiOrio, [NAME] R |  | B-Engineering |  | Equipment Failures | Uploaded cleanroom conditions (in specification) as of 1030AM at which time Facilities verbally notified QC to begin EM.  RRD 24JAN11  DR46447 was reclassified as a Major deviation per CAE (see attached email) AMS 01/24/11 |  |  | USAGBX4990:Facilities | 2011-02-11 15:53:00 | 2011-02-11 15:54:00 | 2011-02-11 15:53:00 | Add requirement in EQ2-040 for Facilities to commission both hot water circulators on RTU-1 and run both pumps in severe cold weather below 10 F.  During the morning check of the room magnehelic guages the carticel degown room guage (C-0809) was reading | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-021 | No cell culture work was performed.  Facilities and QC were contacted. |  |  |  |  | DiOrio, [NAME] R | 46447 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  | MF1-010 | 41321;41549 | No |  |  |  |  |  |  |  |  |  |  |  | The Carticel gown in room ([NAME]) and the Carticel degown room (C-0809) magnehelic readings are below specifications. | Sidney Street | [NAME] |  | n/a |  | Root Cause Analysis and Planning | Services, TrackWise | 2011-02-11 15:54:00
41231 | Ernesti, [NAME] |  | I-QADC |  | Deviations to cGMP/Quality System Requirements/Regulatory Filings | 07Dec10: In response to the MHRA inspection of Allston in October 2009, this preventative action was required. QA approves this preventative action. JPM 07Dec10 |  |  | USAGBX4810:MFG Management | 2010-11-24 15:53:00 | 2010-12-07 08:31:00 | 2010-11-24 15:52:00 | Allston 2009 GRT observation for appropriate manufacturing shutdown times for critical maintenance and facility upgrades or improvements. | 2011-07-01 00:00:00 |  |  |  |  |  |  |  |  |  |  | Heffernan, [NAME] | 2010-11-29 10:45:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-055 |  |  |  | Heffernan, [NAME] |  | Ernesti, [NAME] |  |  |  |  | Ernesti, [NAME] | 2010-11-24 16:03:00 | [NAME], [NAME] | 2010-12-07 08:31:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | MHRA 2009 GRT - Production Shutdowns | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Ernesti, [NAME] | 2010-11-24 15:54:00
44365 | Adams, [NAME] |  | C-Mfg Carticel |  | Management and periodic process reviews | 29Dec10: This preventative action was required after a review of the Lyon FDA inspection from October 2010 as part of the GRT program. As proof of completion, a procedure will be developed that explains the use and reporting from the SPC trending system. |  |  | USAGBX4810:MFG Management | 2010-12-29 14:13:00 | 2010-12-29 14:14:00 |  | In response to GRT review ([NAME]), a trending system is required to monitor the critical process parameters in order to evaluate the current state against the expected (historic) state.  This trending system will utilize n SPC data system t | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-039 |  |  |  |  |  | [NAME], [NAME] | 43739 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Develop SPC trending system program | Sidney Street | [NAME] |  | Lyon FDA October 2010 |  | Work in Progress | Services, TrackWise | 2010-12-29 14:14:00
43911 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews | Observation text:  Equipment used in the manufacture, processing packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. |  |  | USAGBX4990:Facilities | 2010-12-22 10:30:00 | 2010-12-22 10:31:00 |  | Allston FDA Inspection 2009 calls for URS or functional specifications for all new / changed equipment used in manufacturing.  This gap will be met by the Design and Construction of Facilities, Utilities, and Equipment standard.  All site gaps will be rem | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-030 |  |  |  |  |  | [NAME], [NAME] | 43175 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Write and implement SOP for site deployment of Corp. Standard | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-22 10:31:00
42303 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the IMB inspection of 76NYA in October 2009, this prevenative action was required. QA approves this preventative action plan. JPM 07Dec10 |  |  | USAGBX4700:Quality Assurance | 2010-12-07 07:55:00 | 2010-12-07 07:56:00 |  | Publish risk assessment (or gap analysis against corporate standard on Sterilization/Depyrogenation, if available) and identify plan of action, if any. | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-008 |  |  |  |  |  | [NAME], [NAME] | 41098 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Publish risk assessment and determine remediation plan for Depyrogentation study | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-12-07 07:56:00
44450 | [NAME], [NAME] | Z:\Tech Report sign.pdf | B-Engineering |  | Management and periodic process reviews | Proposed action plan completed for review by QA and formation of tasks.  RRD 24 Nov 10  30Dec10: In response to the CQC audit of Lyon in 2010, this preventative action was required. QA approves this preventatative action plan.  Proof of completion will | [NAME], [NAME] | 2011-02-07 14:04:00 | USAGBX4950:Renagel Mfg Other (BioS) | 2010-12-30 11:55:00 | 2011-02-07 14:04:00 |  | Per CQC Lyon 2010 observation 2.4.2:  There is no scientific rationale in place for the five minute delay on the BMS for refrigerator/freezer alarms despite the devices being dampened to address the possibility of nuisance alarms.  Engineering will rese | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-12-040 |  |  |  |  |  | [NAME], [NAME] | 41195 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Generate a Technical Report on alarm delays | Sidney Street | [NAME] |  | N/A |  | Pending QA Review | Services, TrackWise | 2010-12-30 11:56:00
44925 | Bonn, [NAME] |  | I-QADC |  | Management and periodic process reviews | N/A |  |  | USAGBX4700:Quality Assurance | 2011-01-06 10:08:00 | 2011-02-09 15:07:00 | 2011-01-06 10:08:00 | In response to a GRT review QA3-008 (Change Control)does not require effectiveness review post change implementation.  Root Cause: inadequate SOP.  CA:  QA3-008 will be revised to incorporate effectivenss review post change implementation.  Evidence to be | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-007 |  |  |  | [NAME], [NAME] |  | Bonn, [NAME] |  |  |  |  | Bonn, [NAME] | 2011-02-09 15:07:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  | QA3-008 |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:QA3-008 will be revised to include corporate standard requirements including effectiveness review of change | Sidney Street | [NAME] |  | N/A |  | Pending Action Plan Approval | Services, TrackWise | 2011-01-06 10:09:00
43739 | Adams, [NAME] |  | C-Mfg Carticel |  | Management and periodic process reviews |  |  |  | USAGBX4810:MFG Management | 2010-12-21 10:12:00 | 2010-12-29 14:14:00 | 2010-12-21 10:12:00 | In response to GRT review ([NAME]), a trending system is required to monitor the critical process parameters in order to evaluate the current state against the expected (historic) state.  This trending system will utilize n SPC data system t | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Ernesti, [NAME] | 2010-12-21 11:29:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-015 |  |  |  | Ernesti, [NAME] |  | Adams, [NAME] |  |  |  |  | Adams, [NAME] | 2010-12-21 10:14:00 | [NAME], [NAME] | 2010-12-29 14:14:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Develop SPC trending system | Sidney Street | [NAME] |  | n/a |  | Implementation in Progress | Adams, [NAME] | 2010-12-21 10:12:00
43175 | DiOrio, [NAME] R |  | B-Engineering |  | Management and periodic process reviews | Observation text:  Equipment used in the manufacture, processing packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.  In response to the Allston 2009  FDA inspection, this preventative action |  |  | USAGBX4990:Facilities | 2010-12-15 15:37:00 | 2010-12-22 10:32:00 | 2010-12-15 15:37:00 | Allston FDA Inspection 2009 calls for URS or functional specifications for all new / changed equipment used in manufacturing.  This gap will be met by the Design and Construction of Facilities, Utilities, and Equipment standard.  All site gaps will be rem | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-12-15 22:06:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-006 |  |  |  | Entstrasser, [NAME] |  | DiOrio, [NAME] R |  |  |  |  | DiOrio, [NAME] R | 2010-12-15 15:40:00 | [NAME], [NAME] | 2010-12-22 10:32:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Ensure URS for new / changed equipment | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-12-15 15:38:00
41195 | Dulac, [NAME] |  | B-Engineering |  | Management and periodic process reviews | Proposed action plan completed for review by QA and formation of tasks.  RRD 24 Nov 10  30Dec10: In response to the CQC audit of Lyon in 2010, this preventative action was required. QA approves this preventatative action plan.  Proof of completion will |  |  | USAGBX4950:Renagel Mfg Other (BioS) | 2010-11-24 13:57:00 | 2010-12-30 11:57:00 | 2010-11-24 13:57:00 | Per CQC Lyon 2010 observation 2.4.2:  There is no scientific rationale in place for the five minute delay on the BMS for refrigerator/freezer alarms despite the devices being dampened to address the possibility of nuisance alarms. | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-12-13 13:36:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-054 |  |  |  | Entstrasser, [NAME] |  | DiOrio, [NAME] R |  |  |  |  | Dulac, [NAME] | 2010-12-10 13:55:00 | [NAME], [NAME] | 2010-12-30 11:57:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT: Justify BMS alarm delays | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-24 13:58:00
41098 | [NAME], [NAME] |  | K-QAVAL |  | Management and periodic process reviews | 07Dec10: In response to the IMB inspection of 76NYA in October 2009, this prevenative action was required. QA approves this preventative action plan. JPM 07Dec10 |  |  | USAGBX4700:Quality Assurance | 2010-11-23 22:58:00 | 2010-12-07 07:55:00 | 2010-11-23 22:58:00 | Publish risk assessment (or gap analysis against corporate standard on Sterilization/Depyrogenation, if available) and identify plan of action, if any. | 2011-06-30 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2010-11-28 15:19:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-047 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2010-11-24 11:05:00 | [NAME], [NAME] | 2010-12-07 07:55:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:  Assess material hold times post-sterilization | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-23 22:59:00
48547 | D'Alessandro, [NAME] |  | J-QAOPS |  | Management and periodic process reviews |  |  |  | USAGBX4700:Quality Assurance | 2011-02-15 09:45:00 | 2011-02-15 13:03:00 | 2011-02-15 09:44:00 | In response to a GRT review of Haver Hill  Sept 2010, Sidney Street will revise SOP RA1-008 to incorporate an annual Mock Recall.JED15FEB11 | 2011-06-23 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2011-02-15 13:03:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-025 |  |  |  | Entstrasser, [NAME] |  | D'Alessandro, [NAME] |  |  |  |  | D'Alessandro, [NAME] | 2011-02-15 10:07:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT:RA1-008 will be revised to include an annual Mock Recall | Sidney Street | [NAME] |  | N/A |  | Pending QA Approval | D'Alessandro, [NAME] | 2011-02-15 09:55:00
44798 | [NAME], [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: In response to the EMA audit of Allston in November 2010, this preventative action was required. QA approves this preventative action plan. |  |  | USAGBX4800:Quality Control | 2011-01-05 09:22:00 | 2011-01-05 09:23:00 |  | QC will develop a program, or build upon an existing program to assure that validated and compendial test methods are reviewed for compliance, performance and suitability on a regular basis. | 2011-06-08 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-012 |  |  |  |  |  | [NAME], [NAME] | 44713 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Assure that validated and compendial test methods are reviewed for compliance | Sidney Street | [NAME] |  | Allston EMA November 2010 Obs. 4.9 |  | Work in Progress | Services, TrackWise | 2011-01-05 09:23:00
44713 | [NAME], [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: In response to the EMA audit of Allston in November 2010, this preventative action was required. QA approves this preventative action plan. JPM 05Jan11 |  |  | USAGBX4800:Quality Control | 2011-01-04 13:21:00 | 2011-01-05 09:23:00 | 2011-01-04 13:21:00 | QC will develop a program, or build upon an existing program to assure that validated and compendial test methods are reviewed for compliance, performance and suitability on a regular basis. | 2011-06-08 00:00:00 |  |  |  |  |  |  |  |  |  |  | Entstrasser, [NAME] | 2011-01-05 07:47:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-004 |  |  |  | Entstrasser, [NAME] |  | [NAME], [NAME] |  |  |  |  | [NAME], [NAME] | 2011-01-04 13:26:00 | [NAME], [NAME] | 2011-01-05 09:23:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- Develop an Annual QC Method Review Procedure | Sidney Street | [NAME] |  | Allston EMA November 2010 Obs. 4.9 |  | Implementation in Progress | Services, TrackWise | 2011-01-04 13:22:00
42519 | [NAME], [NAME] |  |  |  | Equipment Failures |  |  |  | USAGBX4700:Quality Assurance | 2010-12-09 03:54:00 | 2010-12-09 04:02:00 | 2010-12-09 03:54:00 | CAPA Description: Validation to upload applicable documentation showing repairs to the unit, proper operation of the unit, and to release [NAME] for use by manufacturing.  Deviation Description: During metrology function for the day -20C freezer C-295 | 2011-06-07 00:00:00 |  | 2011-06-30 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  |  |  |  |  | Adams, [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-12-001 |  |  |  |  |  | Adams, [NAME] | 41541 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | Release of [NAME] for use within Manufacturing | Sidney Street | [NAME] |  |  |  | Pending Area Manager Feedback
38970 | Almeida, [NAME] |  | K-QAVAL |  | Equipment Failures | N/A JA 11/04/10 |  |  | USAGBX4700:Quality Assurance | 2010-11-04 15:19:00 | 2010-11-10 16:31:00 | 2010-11-04 15:19:00 | CAPA Description:  Replace existing Humidifiers with new.  Commission and qualify new Humidifiers.  Deviation Description:  Outdoor ambient conditions (low dew point) caused cleanroom relative humidity to fall in the range of 22-29% RH during processing | 2011-06-07 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2010-11-09 11:03:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-008 | None.  Existing humidifiers have been removed from service and are currently being replaced with new units.  Unable to provide humidification until new units are fully commissioned.  Commissioning expected to be complete by week ending 29 Oct 10.  Inabili |  |  | [NAME], [NAME] |  | Almeida, [NAME] | 37359 |  |  |  | Almeida, [NAME] | 2010-11-04 15:28:00 | [NAME], [NAME] | 2010-11-10 16:31:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  | MF1-010 |  | No |  |  |  |  |  |  |  |  |  |  |  | Commission and qualify new Humidifiers | Sidney Street | [NAME] |  | N/A |  | Implementation in Progress | Services, TrackWise | 2010-11-04 15:20:00
47881 | DiOrio, [NAME] R |  | B-Engineering |  | Internal/External audits and inspections |  |  |  | USAGBX4990:Facilities | 2011-02-08 09:43:00 | 2011-02-08 09:44:00 |  | [NAME] to simply state that PM's must be completed by the last day of the period and that there is no grace period for PM's.  [NAME] log requirement. | 2011-06-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-025 |  |  |  |  |  | Kaszuba, Michelle S | 47321 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | EQ2-052;QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-09h Revise EQ2-052 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 09:44:00
47867 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to J. Melo RRD 15Feb 11 |  |  | USAGBX4990:Facilities | 2011-02-08 08:39:00 | 2011-02-08 08:39:00 |  | Revise SOP EQ1-016 to remove unused Step 8.3 | 2011-06-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-017 |  |  |  |  |  | Kaszuba, Michelle S | 47310 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | EQ1-016;QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-04d Revise EQ1-016 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 08:39:00
47866 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 08:38:00 | 2011-02-08 08:39:00 |  | Revise SOP EQ1-004 to remove log sheet | 2011-06-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-016 |  |  |  |  |  | Kaszuba, Michelle S | 47310 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | EQ1-004;QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-04c Revise EQ1-004 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 08:39:00
47865 | [NAME], [NAME] |  | B-Engineering |  | Internal/External audits and inspections | Reassigned to [NAME] 15Feb11 |  |  | USAGBX4990:Facilities | 2011-02-08 08:35:00 | 2011-02-08 08:36:00 |  | Revise SOP EQ2-002 to include inspection of drain opening in Step 8.2 | 2011-06-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-015 |  |  |  |  |  | Kaszuba, Michelle S | 47310 |  |  |  |  |  |  |  | Martin, [NAME] |  |  | Task |  |  |  |  | EQ2-002;QA1-008 |  |  |  |  |  |  |  |  |  |  |  |  |  | 10-015-04b Revise EQ2-002 | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2011-02-08 08:36:00
48253 | Rowe, [NAME] |  | H-QC Material / Product Release |  | Management and periodic process reviews | QA Comment 11Feb11: Per review of the EMA audit of Framingham in 2010, this preventative action was required. The deviation noted in the CAPA description was from the audit observation at Framingham and was not a deviation at Sidney Street. QA approves th |  |  | USAGBX4800:Quality Control | 2011-02-11 08:18:00 | 2011-02-11 08:19:00 |  | The QC inspected materials program SOP QC1-002 needs to be updated in response to the FBS BVDV incident (deviation 29668), to ensure that specifications were not accepted using statements such as ‘tested’ for any critical quality attributes.  This is a GR | 2011-05-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-02-039 |  |  |  |  |  | [NAME], [NAME] | 48044 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | .Revise [NAME] to ensure all vendor COA results received @ Sidney Street are applicable and meet our specifications | Sidney Street | [NAME] |  | EMA Framingham 2010 Observation # 2.1.4.1 |  | Work in Progress | Services, TrackWise | 2011-02-11 08:19:00
39734 | [NAME], [NAME] |  | K-QAVAL |  | Equipment Failures | N/A JA 11/04/10 |  |  | USAGBX4700:Quality Assurance | 2010-11-10 16:30:00 | 2010-11-10 16:31:00 |  | TASK: Perform Installation, Operational and [NAME] on new Humidifiers.  Upload approvals page(s) as evidence of completion.  -------------------------------  CAPA Description:  Replace existing Humidifiers with new.  Commission an | 2011-05-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-11-017 |  |  |  |  |  | [NAME], [NAME] | 38970 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  | MF1-010 |  |  |  |  |  |  |  |  |  |  |  |  |  | Qualify new humidification system. | Sidney Street | [NAME] |  | N/A |  | Work in Progress | Services, TrackWise | 2010-11-10 16:31:00
48044 | Rowe, [NAME] |  | H-QC Material / Product Release |  | Management and periodic process reviews | QA Comment 11Feb11: Per review of the EMA audit of Framingham in 2010, this preventative action was required. The deviation noted in the CAPA description was from the audit observation at Framingham and was not a deviation at Sidney Street. QA approves th |  |  | USAGBX4800:Quality Control | 2011-02-09 11:19:00 | 2011-02-11 08:19:00 | 2011-02-09 11:19:00 | The QC inspected materials program SOP QC1-002 needs to be updated in response to the FBS BVDV incident (deviation 29668), to ensure that specifications were not accepted using statements such as ‘tested’ for any critical quality attributes.  This is a GR | 2011-05-31 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-02-09 11:32:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-015 |  |  |  | [NAME], [NAME] |  | Rowe, [NAME] |  |  |  |  | Rowe, [NAME] | 2011-02-09 11:28:00 | [NAME], [NAME] | 2011-02-11 08:19:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- SOP QC1-002 needs to be updated to ensure that each COA test result is applicable to our specification. | Sidney Street | [NAME] |  | EMA Framingham 2010 Observation # 2.1.4.1 |  | Implementation in Progress | Services, TrackWise | 2011-02-09 11:20:00
25599 | Sellers, Amanda M |  | Quality Assurance |  | Customer complaint | ER due date to be set to 1 year after closure of CAPA. AMS 05/21/10 |  |  | USAGBX4700:Quality Assurance | 2010-05-25 10:35:00 | 2010-05-25 10:35:00 | 2010-05-25 10:35:00 | Revision to 64055.C Essential Kit Carton and [NAME] in response to Product Event 8701 in which  the text on label with regards to sterility of packaging is unclear.  [NAME] to be revised to clarify sterility status of all packaging. | 2011-05-26 00:00:00 |  | 2010-05-26 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  |  |  |  |  | D'Alessandro, [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-05-003 |  |  |  |  |  | Sellers, Amanda M | 25427 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | CAPA to revise 64055.C Essential Kits Label | Sidney Street | [NAME] |  | N/A |  | Pending Area Manager Feedback
25603 | [NAME], [NAME] |  | Quality Assurance |  | Deviation | Extention request until June 1, 2010 attached.  JW  15 MAR 10 |  |  | USAGBX4700:Quality Assurance | 2010-05-25 10:40:00 | 2010-07-14 16:30:00 | 2010-05-25 10:40:00 | CAPA Description: [NAME] to recognize GCQO-QA-SO01 classification definitions   Deviation Description: Current Deviation Classification definitions in QA3-002:  Remark: Used to capture and track potential improvements, suggestions, or observ | 2011-05-26 00:00:00 | This CAPA was intended to drive the revision of QA3-002 to ensure compliance with corporate standard for deviations.  The revision was completed and CAPA was effective. | 2010-05-26 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2010-07-14 16:30:00 |  |  | [NAME], [NAME] |  |  |  |  | 2010-07-14 16:30:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-05-004 |  |  |  |  |  | Kaszuba, Michelle S | 18055 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes | CAPA was effective. |  |  |  |  |  |  |  |  |  |  | [NAME] to recognize GCQO-QA-SO01 classification definitions | Sidney Street | [NAME] |  | N/A |  | Closed - Effective
48605 | Martin, [NAME] |  | J-QAOPS |  |  |  |  |  | USAGBX4700:Quality Assurance | 2011-02-15 14:58:00 | 2011-02-15 14:59:00 | 2011-02-15 14:58:00 | Internal Audit CAPA 09-022-01 found that Sidney Street failed to establish the reliability of the supplier’s analyses through appropriate validation.  This CAPA is to revise QA1-006  to ensure MSRB  identifies the requirements/ reliability of the supplier | 2011-05-18 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-026 |  |  |  |  |  | Martin, [NAME] |  |  |  |  |  |  |  |  | Kaszuba, Michelle S |  |  | CAPA |  |  |  |  | QA1-006 |  | No |  |  |  |  |  |  |  |  |  |  |  | [NAME]  to ensure MSRB  identifies the requirements/reliability of the supplier’s certificate of analysis. | Sidney Street | [NAME] |  | Technical Report # 11-018-TR: Internal Audit CAPA 09-022-01 |  | Root Cause Analysis and Planning | Services, TrackWise | 2011-02-15 14:59:00
48485 | Riley, [NAME] |  | H-QC Material / Product Release |  | Deviations from validation protocols |  |  |  | USAGBX4650:MTS - BIOSURGERY | 2011-02-14 16:27:00 | 2011-02-14 16:28:00 | 2011-02-14 16:27:00 | MTS to develop and validate a pellet culture system to replace alginate culture for the assessment of chondrocyte redifferentiation capacity. | 2011-05-14 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-023 | MTS is writing a report concluding their evaluation and qualification study of alternate Sodium Alginates.  It was based on this report, a recommendation to use the expired lot #4F069OA of Potassium alginate will be issued. |  |  |  |  | Sellers, Amanda M | 39264 |  |  |  |  |  |  |  | Sellers, Amanda M |  |  | CAPA |  |  |  |  | QC2-099, QC2-097, QC1-007 |  | No |  |  |  |  |  |  |  |  |  |  |  | MTS to develop and validate a pellet culture system. | Sidney Street | [NAME] |  | N/A |  | Root Cause Analysis and Planning | Services, TrackWise | 2011-02-14 16:28:00
40661 | D'Alessandro, [NAME] |  | C-Mfg Carticel |  | Confirmed Out of Specification (OOS) |  |  |  | USAGBX4200:Carticel Associates | 2010-11-19 03:52:00 | 2010-12-21 11:47:00 | 2010-11-19 03:52:00 | Effectiveness Review Criteria: Evaluate effectiveness of CAPA 38515 that was for temporarily holding and testing (if needed) Carticel biopsy transport media for a 6 month timeframe.  At the end of the six months, Manufacturing, QA and QC will evaluate th | 2011-05-10 00:00:00 |  | 2011-05-10 00:00:00 | [NAME], [NAME] | Yes |  |  |  |  |  |  |  |  |  |  |  |  | Adams, [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-ER-2010-11-001 |  |  |  |  |  | Adams, [NAME] | 38515 |  |  |  |  |  |  |  |  |  |  | Effectiveness Review |  |  |  |  |  |  | Yes |  |  |  |  |  |  |  |  |  |  |  | Evaluate CAPA 38515 to temporarily hold and test (if needed) Carticel biopsy transport media | Sidney Street | [NAME] |  | N/A |  | Pending Area Manager Feedback
47522 | [NAME], [NAME] |  | G-QC Micro |  | Initial OOS Investigations | Requesting extension on 13 Jan 11 due to potential size of PIAT and CAPA plan based on the number of probably causes.  RRD 13 Jan 11.  Requesting extension of due date from 02 Feb 11 to 10 Feb 11 due to JCG's vacation / out of office around the time whe |  |  | USAGBX4800:Quality Control | 2011-02-03 13:23:00 | 2011-02-03 13:55:00 | 2011-02-03 13:23:00 | QC to evaluate re-sampling volume for "at rest" measurements and adjust method and specifications as required.  At-Rest environmental  monitoring was conducted on 12/16/10.  Site 60, room 202, located between BSC C-2280 and C-2281 was out of specificati | 2011-05-01 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-02-011 | QC manager [NAME] was notified of the action level. [NAME] analyst was notified that IAW QC5-005 for action level, the site is left At-Rest for 20 minutes and then 3 additional readings are taken. Site visit was conducted by QC manager [NAME]. [NAME] |  |  | D'Alessandro, [NAME] |  | DiOrio, [NAME] R | 43315 |  |  |  | [NAME], [NAME] | 2011-02-03 13:55:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  | QC5-007 Step 8.1 ;QC5-005 | 34171;43454 | No |  |  |  |  |  |  |  |  |  |  |  | Site 60 room 202 was out of specification for nonviable particle counts | Sidney Street | [NAME] |  | N/A |  | Pending Action Plan Approval | Services, TrackWise | 2011-02-03 13:24:00
41481 | [NAME], [NAME] |  | G-QC Micro |  | Management and periodic process reviews | Action Plan Proposed - EBN 19Nov10 |  |  | USAGBX4800:Quality Control | 2010-11-29 09:41:00 | 2010-12-01 16:27:00 |  | GRT - Create new SOP governing cleaning/monitoring requirements following HVAC shutdowns.  Update EQ1-006 and QA3-002 to include reference to the new SOP. | 2011-04-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2010-11-065 |  |  |  |  |  | [NAME], [NAME] | 40678 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task | [NAME], [NAME] | 2010-12-01 16:27:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Update QA3-002 with reference to the new procedure | Sidney Street | [NAME] |  | FDA [NAME] 3a-3 |  | Opened | [NAME], [NAME] | 2010-12-01 15:29:00
44691 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA comment 04Jan11: In response to the TGA audit of the Allston Facility in October 2010, this preventative action is required. QA approves this preventative action plan. JPM  04Jan11 |  |  | USAGBX4800:Quality Control | 2011-01-04 11:15:00 | 2011-01-04 11:16:00 |  | Create or revise SOP(s) to include instructions for sending microbial identifications to contract lab for analysis and to add guidance to the SOP(s) for the minimum level of ID required and what to do when that level cannot be obtained. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-007 |  |  |  |  |  | [NAME], [NAME] | 44656 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Generate a procedure to send microbial ids to contract lab | Sidney Street | [NAME] |  | GRT Observation 8J |  | Work in Progress | Services, TrackWise | 2011-01-04 11:16:00
44667 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews |  |  |  |  | 2011-01-04 09:48:00 | 2011-01-04 09:49:00 |  | Add specific instructions to QC SOPs and/or add MFG SOP references for cleaning and maintenance required when using EM equipment in classified areas and BSCs. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-006 |  |  |  |  |  | [NAME], [NAME] | 44421 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] to add procedure to disinfect equipment | Sidney Street | [NAME] |  | FDA Lyon October Observation B |  | Work in Progress | Services, TrackWise | 2011-01-04 09:49:00
44665 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA comment 04Jan11: In response to the FDA inspection of the [NAME] facility in October 2010, this prevenative action was required. QA approves this preventative action plan. JPM 04Jan11 |  |  | USAGBX4800:Quality Control | 2011-01-04 09:42:00 | 2011-01-04 09:43:00 |  | Add specific instructions to QC SOPs and/or add MFG SOP references for cleaning and maintenance required when using EM equipment in classified areas and BSCs. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-005 |  |  |  |  |  | [NAME], [NAME] | 44421 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] to add procedure to disinfect tubing and equipment | Sidney Street | [NAME] |  | FDA Lyon October Observation B |  | Work in Progress | Services, TrackWise | 2011-01-04 09:43:00
38412 | Prinzi, [NAME] |  | G-QC Micro |  | Investigations from other quality processes | CAPA should be issued to track completion of overdue 2010 monthly environmental monitoring reports.  EBN 17Dec10 |  |  | USAGBX4800:Quality Control | 2010-10-29 15:05:00 | 2010-10-29 15:05:00 | 2010-10-29 15:05:00 | A. Failed to issue Monthly reports two weeks after the beginning of the month as required at step 7.2.  This affects the reports from August through November.   CA- issue late reports.  Issue invites for 2010 to ensure meeting attendees are aware of meeti | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-10-018 |  |  |  | [NAME], [NAME] |  | [NAME], [NAME] | 28512 |  |  |  |  |  |  |  | D'Alessandro, [NAME] |  |  | CAPA |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | CAPA for DR 17697- Failure to issue monthly EM Trend Reports August - November. | Sidney Street | [NAME] |  | DR# 17697 |  | Root Cause Analysis and Planning | Services, TrackWise | 2010-10-29 15:05:00
44656 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA comment 04Jan11: Per the TGA audit of the Allston Facility in October 2010. this preventative action is required. QA approves this preventative action plan. JPM  04Jan11 |  |  | USAGBX4800:Quality Control | 2011-01-04 09:00:00 | 2011-01-04 11:18:00 | 2011-01-04 09:00:00 | Create or revise SOP(s) to include instructions for sending microbial identifications to contract lab for analysis and to add guidance to the SOP(s) for the minimum level of ID required and what to do when that level cannot be obtained. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-04 10:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-002 |  |  |  | [NAME], [NAME] |  | Prinzi, [NAME] |  |  |  |  | Prinzi, [NAME] | 2011-01-04 09:39:00 | [NAME], [NAME] | 2011-01-04 11:18:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT - No procedure for sending microbial isolates for ID | Sidney Street | [NAME] |  | GRT Observation 8J |  | Implementation in Progress | Services, TrackWise | 2011-01-04 09:01:00
44421 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 04Jan11: In response to the FDA inspection of the [NAME] facility in October 2010,  this preventative action was required.  QC5-007 and QC5-009 will be evaluated for edits. Any MF documents will be assessed for references and changes will done if |  |  | USAGBX4800:Quality Control | 2010-12-30 08:06:00 | 2011-01-04 11:35:00 | 2010-12-30 08:05:00 | Add specific instructions to QC SOPs and/or add MFG SOP references for cleaning and maintenance required when using EM equipment in classified areas and BSCs. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-04 08:56:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-12-025 |  |  |  | [NAME], [NAME] |  | Prinzi, [NAME] |  |  |  |  | Prinzi, [NAME] | 2011-01-04 08:22:00 | [NAME], [NAME] | 2011-01-04 11:35:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- Clarify SOPs for cleaning, maintenance and / or replacement of EM equip. | Sidney Street | [NAME] |  | FDA Lyon October Observation B |  | Implementation in Progress | Services, TrackWise | 2010-12-30 08:07:00
44695 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 04Jan11: In response to the FDA inspection of the [NAME] facility in October 2010,  this preventative action was required.  QC5-007 and QC5-009 will be evaluated for edits. Any MF documents will be assessed for references and changes will done if |  |  | USAGBX4800:Quality Control | 2011-01-04 11:32:00 | 2011-01-04 16:38:00 |  | Add specific instructions to QC SOPs and/or add MFG SOP references for cleaning and maintenance required when using EM equipment in classified areas and BSCs. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2011-01-04 16:38:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-009 |  |  |  |  |  | [NAME], [NAME] | 44421 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] to add procedure to disinfect equipment | Sidney Street | [NAME] |  | FDA Lyon October Observation B |  | Closed - Void | Services, TrackWise | 2011-01-04 11:33:00
44694 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 04Jan11: In response to the FDA inspection of the [NAME] facility in October 2010,  this preventative action was required.  QC5-007 and QC5-009 will be evaluated for edits. Any MF documents will be assessed for references and changes will done if |  |  | USAGBX4800:Quality Control | 2011-01-04 11:31:00 | 2011-01-04 16:38:00 |  | Add specific instructions to QC SOPs and/or add MFG SOP references for cleaning and maintenance required when using EM equipment in classified areas and BSCs. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2011-01-04 16:38:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-008 |  |  |  |  |  | [NAME], [NAME] | 44421 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] to add procedure to disinfect tubing and equipment | Sidney Street | [NAME] |  | FDA Lyon October Observation B |  | Closed - Void | Services, TrackWise | 2011-01-04 11:32:00
40672 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | This does not fall under GRT and  needs to be void. SP 12/10/10 |  |  | USAGBX4800:Quality Control | 2010-11-19 07:33:00 | 2010-12-16 14:23:00 | 2010-11-19 07:33:00 | GRT- [NAME] to include disinfectant contact times prescribed in the Genzyme global disinfectant study 10-TRN-177 | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2010-11-22 13:31:00 |  |  |  |  |  |  |  |  |  | 2010-12-16 14:23:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2010-11-029 |  |  |  | [NAME], [NAME] |  | [NAME], [NAME] |  |  |  |  | Prinzi, [NAME] | 2010-11-22 13:20:00 |  |  | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT- [NAME] to include disinfectant contact times | Sidney Street | [NAME] |  | Global Disinfection Standard |  | Closed - Void | Services, TrackWise | 2010-11-19 07:34:00
44664 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: As a result of the TGA inspection of the Allston facility in October 2010, this preventative action was required. QA approves this preventative action plan. JPM 05Jan11  QA Comment 26Jan11: Tasks 44808, 44810 and 44812 have all been |  |  | USAGBX4800:Quality Control | 2011-01-04 09:35:00 | 2011-01-26 14:13:00 | 2011-01-04 09:35:00 | There is currently no requirement for the staff to decontaminate hands on entry or exit from the laboratory. | 2011-04-29 00:00:00 |  |  |  | No |  |  |  | [NAME], [NAME] | 2011-01-26 11:48:00 |  | [NAME], [NAME] | 2011-01-04 13:32:00 | [NAME], [NAME] | 2011-01-26 14:13:00 |  |  |  |  |  |  |  | 2011-01-26 14:13:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-CAPA-2011-01-003 |  |  |  | [NAME], [NAME] |  | Prinzi, [NAME] |  |  |  |  | Prinzi, [NAME] | 2011-01-04 09:46:00 | [NAME], [NAME] | 2011-01-05 10:22:00 | [NAME], [NAME] |  |  | CAPA |  |  |  |  |  |  | No |  |  |  |  |  |  |  |  |  |  |  | GRT - No requirement for staff to decontaminate hands leaving laboratory | Sidney Street | [NAME] |  | GRT - Observation 44 |  | Closed - Done | Services, TrackWise | 2011-01-04 09:36:00
44812 | Prinzi, [NAME] | Z:\Hand Sanitizer for GRT Response.pdf | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: As a result of the TGA inspection of the Allston facility in October 2010, this preventative action was required. QA approves this preventative action plan. JPM 05Jan11  QA Comment 26Jan11: The laboratory staff has been trained to de | Prinzi, [NAME] | 2011-01-25 14:36:00 | USAGBX4800:Quality Control | 2011-01-05 10:21:00 | 2011-01-26 10:38:00 |  | There is currently no requirement for the staff to decontaminate hands on entry or exit from the laboratory. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-26 10:38:00 |  |  |  |  |  |  |  | 2011-01-26 10:38:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-017 |  |  |  |  |  | [NAME], [NAME] | 44664 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  | [NAME], [NAME] | 2011-01-21 09:45:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Laboratory personnel will be trained | Sidney Street | [NAME] |  | GRT - Observation 44 |  | Closed - Done | Services, TrackWise | 2011-01-05 10:22:00
44810 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: As a result of the TGA inspection of the Allston facility in October 2010, this preventative action was required. QA approves this preventative action plan. JPM 05Jan11  QA Comment 21Jan11: On 21Jan11, [NAME] (QC Microbiology) an | Prinzi, [NAME] | 2011-01-21 08:08:00 | USAGBX4800:Quality Control | 2011-01-05 10:17:00 | 2011-01-21 09:44:00 |  | There is currently no requirement for the staff to decontaminate hands on entry or exit from the laboratory. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-21 09:44:00 |  |  |  |  |  |  |  | 2011-01-21 09:44:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-016 |  |  |  |  |  | [NAME], [NAME] | 44664 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Sign will be added to door or wall stating to sanitize hands | Sidney Street | [NAME] |  | GRT - Observation 44 |  | Closed - Done | Services, TrackWise | 2011-01-05 10:19:00
44808 | Prinzi, [NAME] |  | G-QC Micro |  | Management and periodic process reviews | QA Comment 05Jan11: As a result of the TGA inspection of the Allston facility in October 2010, this preventative action was required. QA approves this preventative action plan. JPM 05Jan11  QA Comment 21Jan11: On 21Jan11, S. Prinzi (QC Microbiology) and | Prinzi, [NAME] | 2011-01-21 08:04:00 | USAGBX4800:Quality Control | 2011-01-05 10:16:00 | 2011-01-21 09:39:00 |  | There is currently no requirement for the staff to decontaminate hands on entry or exit from the laboratory. | 2011-04-29 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  | [NAME], [NAME] | 2011-01-21 09:39:00 |  |  |  |  |  |  |  | 2011-01-21 09:39:00 |  |  |  |  |  |  |  |  |  |  |  | USMA05-Task-2011-01-015 |  |  |  |  |  | [NAME], [NAME] | 44664 |  |  |  |  |  |  |  | [NAME], [NAME] |  |  | Task |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Hand sanitizer will be installed outside laboratory room 335 | Sidney Street | [NAME] |  | GRT - Observation 44 |  | Closed - Done | Services, TrackWise | 2011-01-05 10:17:00