![The new Process Validation Guideline by FDA, On a total of 20 pages and subdivided into 7 chapters, the FDA now describes their current thinking with regard to process validation. The chapters are subdivided into: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Revised Process Validation
- 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:
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