Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

This highly interactive two day seminar on raw material requirements in a cGMP environment will:

• Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements
• Review latest updates to include 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.
• Review packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.
• Explore ASQ testing to include how to choose attributes and sample size.
• Determine when the ASQ vs. square root of N+1 is appropriate.

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