The document summarizes the key changes in the 2011 FDA guidance on process validation from the 1987 guidance. It outlines a three-stage approach to process validation: 1) process design, 2) process qualification, and 3) continued process verification. The 2011 guidance emphasizes process understanding, use of statistical methods, and alignment with product lifecycles. It also revises concepts like worst-case conditions, revalidation, and allows matrix and concurrent validation approaches under certain circumstances.

1. USFDA- Guidance for Industry Process Validation: General Principles and Practices 2011 By: Akhilesh Kumar Dwivedi Dr. Reddy’s Labs. F.T.O-III Date: 21 Feb. 2011

9. 9 Focus on alignment with ‘product lifecycle’ ICH Q8/Q8(R) - Pharmaceutical Development PAT Guidance ICH Q9 – Quality Risk Management ICH Q10 – Pharmaceutical Quality Systems Product Design Process Design Scale-up & Transfer Commercial Manufacture Product

10. Process Validation = Lab Studies + Development History + Commercial Scale-up Manufacturing @ Target Values + On-going Monitoring

13. • Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. • Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. • Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control. The new guidance has been aligned with this concept, giving the following three-stage approach to process validation:

29. Any Question...

30. Thank You..