Pharmaceuticals 2012 - FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs

This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such.

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1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.

Areas Covered in the seminar:
- 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