INTERNATIONAL
CONFERENCE ON HARMONISATION ("ICH-Q7A") GUIDELINES APPLICABLE TO THE MANUFACTURE
OF ACTIVE PHARMACEUTICAL INGREDIENTS FOR HUMAN USE IN THE UNITED STATES
INCLUDING CURRENT FDA POLICIES AND GUIDANCE DOCUMENTS AND INDUSTRY PRACTICES
APPLICABLE TO THE MANUFACTURE OF API, WHICH MAY BE MODIFIED OR AMENDED
THROUGHOUT THE TERM OF THIS AGREEMENT.
1.9
"CONTAINERS" IS DEFINED IN THE QUALITY AGREEMENT.
1.10
"DELIVERABLES" SHALL MEAN, WITH RESPECT TO EACH BATCH, THE HAUSER
RELEASE CERTIFICATE (IF APPLICABLE), A COPY OF THE COMPLETED AND APPROVED
MANUFACTURING BATCH RECORD, A COPY OF ANY DEVIATION OR INVESTIGATIONAL REPORTS,
THE CERTIFICATES OF ANALYSIS FOR ALL RAW MATERIALS AND CONTAINERS USED, THE
HAUSER CERTIFICATE OF ANALYSIS FOR THE API AND THE PACKAGED API.
1.11
"FACILITY" AND "FACILITIES" SHALL MEAN HAUSER'S GUNBARREL FACILITY AT
4750 NAUTILUS COURT S., BOULDER, COLORADO 80301 AND HAUSER'S CLEAR CREEK
FACILITY LOCATED AT 6880 N. BROADWAY SUITE H, DENVER, COLORADO 80221.
1.12
"FAILED BATCH" SHALL MEAN ANY BATCH (A) WHICH DOES NOT CONFORM TO THE
REQUIREMENTS OF THE SPECIFICATIONS, OR (B) FAILS TO MEET A CGMP REQUIREMENT, OR
(C) WAS NOT PROCESSED IN ACCORDANCE WITH THE MASTER PRODUCTION RECORD AS ALLOWED
BY CGMP, SUCH THAT IDENTITY, PURITY, STRENGTH OR POTENCY IS COMPROMISED.
1.13
"FDA" IS DEFINED IN THE QUALITY AGREEMENT.
1.14
"GUNBARREL FACILITY" SHALL MEAN HAUSER'S GUNBARREL FACILITY AT 4750
NAUTILUS COURT S. BOULDER, COLORADO 80301.
1.15
"HAUSER'S APPROVAL DATE" IS DEFINED IN THE QUALITY AGREEMENT
1.16
"HAUSER CERTIFICATE OF ANALYSIS" SHALL MEAN A CERTIFICATE ISSUED BY
HAUSER DOCUMENTING THE FINAL API ANALYTICAL TEST RESULTS AND INDICATING WHETHER
OR NOT API SPECIFICATIONS ARE MET.
1.17
"HAUSER RELEASE CERTIFICATE" SHALL MEAN A LETTER OR OTHER DOCUMENT
ISSUED BY HAUSER FOR A BATCH, CERTIFYING THAT THE API SPECIFICATIONS HAVE BEEN
MET, AND THAT PER HAUSER'S REVIEW THE BATCH COMPLIES WITH CGMPS AND THE BATCH
RECORD IS COMPLETE AND ACCURATE.
1.18
"HAZARDOUS WASTE" IS DEFINED IN THE QUALITY AGREEMENT.
1.19
"EXCEPTION REPORT" SHALL MEAN A REPORT INDICATING ANY DEVIATION FROM
THE PROCESSING PROCEDURES OR SPECIFICATIONS SET FORTH IN THE MASTER PRODUCTION
RECORD.
2
1.20
"MASTER PRODUCTION RECORD" IS DEFINED IN THE QUALITY AGREEMENT.
1.21
"MATERIAL REVIEW BOARD" SHALL MEAN A COMMITTEE THAT REVIEWS DEVIATIONS
AND OUT OF SPECIFICATION RESULTS FOR RAW MATERIALS, IN-PROCESS MATERIALS AND
API, AND DETERMINES THE ACTIONS NEEDED TO INVESTIGATE THE DEVIATION, THE
CORRECTIVE/PREVENTIVE ACTION, AND DISPOSITION OF THE PRODUCT. THE MRB IS
COMPOSED OF MANAGEMENT REPRESENTATIVES FROM QUALITY ASSURANCE, QUALITY CONTROL,
AND MANUFACTURING.
1.22
"MSDS" IS DEFINED IN THE QUALITY AGREEMENT.
1.23
"NDA" SHALL MEAN NEW DRUG APPLICATION.
1.24
"NDA SUPPLEMENT" SHALL MEAN A SUPPLEMENTAL FILING TO A NDA.
1.25
"NON-HAZARDOUS WASTE" IS DEFINED IN THE QUALITY AGREEMENT.
1.26
"PENTOSTATIN CRUDE CONCENTRATE" SHALL MEAN PENTOSTATIN CRUDE
CONCENTRATE AS SUPPLIED TO HAUSER BY SUPERGEN OR PARTIES AUTHORIZED BY SUPERGEN.
1.27
"PENTOSTATIN NDA SUBMISSIONS" SHALL MEAN DOCUMENTS, RECORDS AND DATA
SUBMITTED AS PART OF THE PENTOSTATIN NDA.
1.28
"PROCESS", "PROCESSED" OR "PROCESSING" SHALL MEAN THE PHARMACEUTICAL
PROCESSING PROCEDURES FOR THE DELIVERABLES AS DESCRIBED IN THE MASTER PRODUCTION
RECORD AS ALLOWED BY CGMP.
PROCESSING WILL BE PERFORMED