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FDA “Quality By Design” Initially Focuses On Post-Approval Manufacturing

Executive Summary

FDA will focus initially on the post-approval regulatory pathway as the most likely starting point for firms instituting "quality by design" manufacturing

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GMP risk model advisory committee

FDA development of a risk model for good manufacturing practices will be discussed by the Manufacturing Subcommittee of the Pharmaceutical Science Advisory Committee July 20. The subcommittee will hear updates on manufacturing science and quality by design efforts. The subcommittee last discussed the topic at its September 2003 meeting (1"The Pink Sheet" Sept,. 29, 2003, p. 40). On July 21, the subcommittee will consider a quality system approach for the production of investigational new drugs and provide comments on manufacturing science and risk-based questions for new drug application chemistry, manufacturing & controls review processes. The meeting will be held at CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m. [To 2watch a webcast or order a video/DVD of this meeting, go to FDAAdvisoryCommittee.com.]...

GMP risk model advisory committee

FDA development of a risk model for good manufacturing practices will be discussed by the Manufacturing Subcommittee of the Pharmaceutical Science Advisory Committee July 20. The subcommittee will hear updates on manufacturing science and quality by design efforts. The subcommittee last discussed the topic at its September 2003 meeting (1"The Pink Sheet" Sept,. 29, 2003, p. 40). On July 21, the subcommittee will consider a quality system approach for the production of investigational new drugs and provide comments on manufacturing science and risk-based questions for new drug application chemistry, manufacturing & controls review processes. The meeting will be held at CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m. [To 2watch a webcast or order a video/DVD of this meeting, go to FDAAdvisoryCommittee.com.]...

FDA’s Overhaul Of GMP Oversight Will Include Numerous Targeted Guidances

FDA is developing an ad hoc guidance process for manufacturing issues through which it will issue short recommendations based on specific circumstances

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