|
|
|
| |
The Quality Assurance and Regulatory Compliance Department is responsible for establishing and implementing Avid Bioservices quality policies and ensuring compliance with appropriate drug cGMPs. Four major components comprise Quality Assurance at Avid Bioservices:
|
Quality System: The Quality System has been established to ensure the proper release and/or rejection of raw materials, intermediates, packaging and labeling materials as well as the appropriate review and approval of all specifications, SOPs and Master Production Records. The Quality System also ensures the appropriate review and investigation of any deviations. Further, the Quality System ensures that effective systems are in place for maintaining and calibrating all critical equipment. Finally, the Quality System ensures the proper management review of the entire quality process.
Validation: The Validation Master Plan guides our validation activities and supports customer-specific process validation. This group has developed a range of assays to support the comprehensive cleaning validation program used in the manufacturing facility. These include both specific assays for products and cleaning reagents for the determination of total organic carbon and endotoxin. Assays are validated in line with regulatory requirements.
At Avid Bioservices, validations are a critical step to ensure the highest quality of your product and to maintain compliance with the following guidance documentation.
-
FDA CDRH Medical Device Quality Systems Manual "Process Validation", December 1996
-
FDA CDRH/CDER Guideline on the General Principles of Process Validation, May 1987
-
Global Harmonization Task Force Study Group 3 - Quality Systems "Process Validation Guidance for Medical Devices Manufacturers - Final Document", June 29, 1999
-
ANSI/AAMI/ASQC Q9001-1994 Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, August 1, 1994
-
EN 46001:1997 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001, August 1996
-
FDA 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, Proposed Rule, Federal Register, May 3, 1996
-
FDA 21 CFR 820 Medical Devices; Current Good Manufacturing Practice, Final Rule; Quality System Regulation, October 1996
-
FDA "Guide to Inspection of Validation of Cleaning Processes, July 1993
-
FDA "Guide to Inspections of High Purity Water Systems", July 1993
-
Other guidelines as applicable including AAMI, PDA
Document Control: While an important aspect of the Quality System, document control also ensures a policy of maintaining complete confidentiality of all documentation provided by our customers. This group is also responsible for issuing, reviewing and maintaining all records associated with manufacturing and the quality process.
GMP Training : Training is very important to the entire process. Avid adheres to a policy of ensuring that the appropriate individuals are trained and that such training is documented. This includes training in cGMPs.
Auditing: To verify and ensure compliance with the principles of cGMPs, regular audits of the process are conducted with the appropriate corrective actions and follow-up. Additionally, there is a regular schedule for the auditing of critical suppliers.
|
