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

"How various types of raw materials may impact the user"
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. The objective of this two day highly interactive ComplianceOnline seminar is to .. continue reading explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework to include ICH Q7, Q9 and Q11. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Highlights

• 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.
• Review the use of individual samples vs. composite samples for testing.
• Explore ASQ testing to include how to choose attributes and sample size

Speakers

Speaker

Barry A. Friedman, Ph.D

Consultant

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