About cGMP Raw Material Requirements Seminar
This highly interactive two day seminar on raw material requirements in a cGMP environment will:
Consider FDA, Health Canada, ICH, USP and EP requirements.Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production.
Cover testing requirements during each Phase (Phase appropriate), to include microbial and endotoxin, and what may be optional (regulatory risk) until the product moves to its next Phase.
Determine what options exist – even within a Phase 2 or Phase 3 testing framework.
Discuss compendial vs. non-compendial testing and how to respond when no method is available.
Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing.
Explore the number of lots required for testing before reduced testing might occur and why some companies don’t accept this route.
Review the use of individual samples vs. composite samples for testing.
Explore ASQ testing to include how to choose attributes and sample size