FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs

Why Should You Attend:

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such.

• Background and rationale for guidance and proposed regulation.
• Scope.
• CGMP Statutory and Regulatory Requirements.
• Recommendations for complying with the statue- personnel,Quality Control Function, facility and Equipment, Control of Components, Production and Documentation, Laboratory Controls,Container Closure and Labeling, Distribution and Record keeping.
• Special production situations.
• Biological and Biotechnological Products.
• Sterile products/aseptically processed products.
• Questions.