Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live presentation will extensively review this area. It will also delve into the renewed issue of microbial contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on this. It will also focus upon the revised ICH Q7 “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients“ which was revised in September 2016. 

Learning Benefits:

• How to develop an overall strategy for testing raw materials in phase 1 through phase 3 environment. 
• What raw material testing is required during various phases of clinical trials.
• What your certificate of analysis may tell you.
• How to manage non-compendial testing.
• Issues with small vs. large molecules.
• Types of raw materials and their concerns to the user.
• Impact of raw materials receipt in the timely production of a product.
• Review of validation criteria and recommendations for satisfying each as part of a microbiological validation.
• What is the single largest used raw material in large molecule production.
• Sources of analyses assistance for raw materials.
• Initiation of additional testing - when?
• Observe warning letters related to raw material issues.