References
1. FDA, "Submission of Chemistry, Manufacturing and Controls Information in a New Drug Application Under the New Pharmaceutical
Quality Assessment System; Notice of Pilot Program," Fed. Regist.
70 (134), 40719–40720, (July 14, 2005).
2. FDA, "Pharmaceutical cGMP's for the 21st Century–A Risk-Based Approach, Final Report," (Rockville, MD, September 2004),
http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm, accessed Sept. 8, 2009.
3. ICH, Q8(R2) Pharmaceutical Development, Step 4 version (Geneva, August 2009).
4. ICH, Q9 Quality Risk Management (Geneva, Nov. 2005).
5. ICH, Q10 Pharmaceutical Quality System (Portland, OR, June 2008).
6. FDA, Gudiance for Industry: PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, September 2004)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf, accessed Sept. 8, 2009.
7. FDA, Draft Guidance for Industry: Comparability Protocols—Chemistry, Manufacturing and Controls Information (Rockville, MD, February 2003)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070545.pdf, accessed Sept. 9, 2009.
8. FDA, Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Rockville, MD, 2006),
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf, accessed Sept. 9, 2009.
9. ICH, M4Q (R1) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality—M4Q (R1), Quality Overall Summary
of Module 2, Module 3: Quality (Geneva, Sept. 2002).
10. P.S. Hudson and D.D. Baker, "The Postapproval Management Plan—A Tool to Apply Science and Risk-Based Approaches," Pharm. Technol., 33 (1), 82–86 (2009).
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