Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot - Pharmaceutical Technology

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Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot
Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.

Pharmaceutical Technology
Volume 33, Issue 10, pp. 96-102


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),, 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), accessed Sept. 8, 2009.

7. FDA, Draft Guidance for Industry: Comparability Protocols—Chemistry, Manufacturing and Controls Information (Rockville, MD, February 2003), accessed Sept. 9, 2009.

8. FDA, Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Rockville, MD, 2006),, 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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