OtherConference Proceeding
Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
John Eltermann
PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 694-697; DOI: https://doi.org/10.5731/pdajpst.2011.00845
References
- 1.↵
GlaxoSmithKline statement on new information relating to manufacture of Rotarix (rotavirus vaccine), March 22, 2010.
- 2.↵
ICH Q5A (R1)—Quality of Biological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.
- 3.↵
Guidance for Industry: CGMP for Phase I Investigational Drugs, July 2008.
- 4.↵
- 5.
Code of Federal Regulations (CFR) Title 21, Parts 210, 211, 312, and 600, U.S. Government Printing Office, Washington DC, 2011.
- 6.
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls and Establishment Description for a Vaccine or Related Product, 1999.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
John Eltermann
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 694-697; DOI: 10.5731/pdajpst.2011.00845
Jump to section
- Article
- Abstract
- Lessons from Post-Approval Issues
- Identification of the Risk and Control Issues
- Facilities and Equipment
- Personnel
- Materials
- Manufacturing Process
- Testing
- Reviews and Inspectional issues—Appropriate Controls Start at the IND Phase of the Product Lifecycle
- Conclusion
- Conflict of Interest
- Acknowledgments
- References
- References
- Info & Metrics
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