This live training webinar will also examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase. It will determine what options exist -- even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. The presentation will also discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay your initiation of testing. Further, it will consider packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.
The live training webinar will explore the number of lots required to be tested before reduced testing might occur and why some Companies don't accept this path. It will also review the use of individual samples vs. composite samples for testing.
The objective of this interactive webinar is to explore raw materials in a cGMP environment, their requirements and how they may affect the time line of meeting the release date of a product.
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 (API)“ which was revised in September 2016.
- Developing an Overall Strategy,
- Testing as a Strategy(FDA Considerations),
- (Other Considerations),
- Issues Associated with Raw Materials,
- Quality Control Review,
- Warning Letters - Raw Materials,
- Live Questions & Discussion
- 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.
- Packaging and storage requirements and their impact on in-coming materials
- 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.
Who Will Benefit
The following individuals or disciplines will benefit from attending this Webinar:
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
This live training webinar includes the following for each registered attendee:
A copy of the presentation slides
A certificate of participation for attendee training records