Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

September 17, 2003

Briefing Information

Cover Letter From Dr. Ajaz Hussain, PhD, FDA (HTM) (PDF) (Word)

Index (HTM) (PDF) (Word)

ICH Concept Paper: Proposal for Preparation of a Quality Guideline on Pharmaceutical Development (PDF)

ICH Conclusions From Informal Discussion Group (PDF)

Guidance for Industry Drug Product-Chemistry, Manufacturing, and Controls Information (PDF)

Guidance for Industry-Process Analytical Technologies (PAT) A Framework for Innovative Manufacturing and Quality Assurance Draft Guidance (PDF)

Pharmaceutical Science Transcript for July 19, 2001 (HTM) (PDF) (Word)

Pharmaceutical Science Transcript for October 21, 2002 (HTM) (PDF) (Word)

Changes Without Prior Approval- Breakout Session Summary, Rick Smith, Aventis Pasteur, Inc. (HTM) (PPT)

Integrating CMC Review & Inspection - Industry Recommendations, Joe Anisko (HTM) (PPT)

Risk-Based cGMPs: Defining Risk and Quality, Summary of Stakeholder Comments April 23, 2003 (HTM) (PPT)

PQRI/FDA Workshop Report, June 16, 2003 (HTM) (PDF) (Word)

Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (PDF)