Pharmaceutical Manufacturing Subcommittee of the ACPS
Ajaz S. Hussain, Ph.D.
ACPS Meeting October 22, 2002
Ensuring Product Quality and Performance
Assurance of quality
Assurance of unchanged
performance characteristics
Product
Specifications
Tests, controls and cGMP
Safety
&
Efficacy
Additional
Tests - PAC
System
USP
Background Information
Pharmaceutical manufacturing
Critical component
Quality and efficiency
R&D and Manufacturing
Review and Inspection
FDA's PAT initiative
FDA's initiative "cGMP for the 21st Century"
Manufacturing Subcommittee
Provide input/advice to CDER/FDA
Science based CMC and cGMP policy development
Continued development of the PAT initiative
cGMP for the 21st Century: A Risk Based Approach
Manufacturing Subcommittee
Modeled after the PAT Subcommittee
Core membership based on expertise in manufacturing and quality assurance
Some members of the PAT subcommittee will be invited to participate (sunset PAT Subcommittee)
Focused working groups or fact finding groups (sunset after assignment is completed)
Initial topics
Selected immediate steps outlined in the cGMP for the 21st Century concept paper
Pharmaceutical cGMP's for the 21st Century:
A Risk Based Approach
Over the last two decades ….
Increased number of pharmaceuticals and their greater role in health care

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