Assessing Risks of Changing Sterile Drug Manufacturing Sites

8. References

1. 1.↵
   FDA. FDA-SOL-08-0064: Assessing Risks of Changing Sterile Drug Manufacturing Sites. Department of Health and Human Services, Food and Drug Administration. May 2008. The objective of the contract is to demonstrate that risks due to changing the manufacturing site can be managed strictly within the manufacturer's change control process so that a supplement to an application is not required.
2. 2.↵
   FDA. Guidance for Industry: Q9 Quality Risk Management. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), June 2006.
3. 3.↵
   M-07-24: Memorandum for the Heads of Executive Departments and Agencies; Subject: Updated Principles for Risk Analysis; Susan E. Dudley, Administrator, Office of Information and Regulatory Affairs, OMB; Sharon L. Hays, Associate Director and Deputy Director for Science, OSTP; Sept 2007.
4. 4.↵
   PDA Quality Risk Management Task Force. PDA Technical Report No. 44: Quality Risk Management for Aseptic Processes. Supplement Volume 62, No. S-1, April 2008. The purpose of this technical report is to provide an overview of a quality risk management program and to present a model to facilitate the risk assessment of aseptic processing.
5. 5.↵
   PQRI Post Approval Changes for Sterile Products Working Group. PQRI Report: Post Approval Changes for Sterile Products. March 2007. The intent of the report, as described in the approved work plan, is to provide regulatory CM&C information that will be of value when considering the development of a Post Approval Guidance for Sterile Drug Products for Human, Veterinary, and Well Characterized Biological Products.
6. 6.↵
   FDA. Guidance for Industry: for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). November 1994.
7. 7.↵
   FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Office of Regulatory Affairs (ORA). September 2004.
8. 8.↵
   FDA. Manual of Policies and Procedures: MAPP 5040.1. Product Quality Microbiology Information in the Common Technical Document—Quality, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science (OPS). May 2004.
9. 9.↵
   FDA. Guidance for Industry: ICH-M4Q. The Common Technical Document—Quality, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). August 2001.
10. 10.↵
    FDA. Guidance for Industry: Changes to an Approved NDA or ANDA. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). April 2004.
11. 11.↵
    FDA. Guidance for Industry: Comparability Protocols—Chemistry, Manufacturing, and Controls Information (Draft Guide). U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM). February 2003.