DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)" conference to their offering.
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
Common questions asked by the users of Process Validation include;
- How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge?
- Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated?
- To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3?
- Does it follow along or with Stage 3? Questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein.
Day 01 (8:30 AM - 5:00 PM)
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
- Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
- Interaction of the Three Stages with Process Validation
- Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
- The Requirements of Phase 1 Investigational Drug Requirements
- Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
Day 02 (8:30 AM - 4:30 PM)
- General Considerations for Process Validation - Stage 2 Process Qualifications
- Special Considerations for Process Validation - Stage 2
- General Considerations for Process Validation - Stage 3 Continued Process Verification
- A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance
- Concurrent Release of Process Performance Qualification (PPQ) Batches
- Analytical Methodology and Process Validation; Warning Letter examples
For more information about this conference visit http://www.researchandmarkets.com/research/vs24wz/process