Unit 13: Process Validation
Process validation provides documented assurance that a manufacturing process consistently delivers products meeting quality standards. It includes design, qualification, and ongoing verification as per FDA, ICH, and GMP guidelines.
Definition
Process validation is documented evidence that a manufacturing process consistently produces a product meeting predetermined specifications and quality attributes.
It ensures reproducibility, compliance with GMP, and patient safety. Regulatory bodies like FDA and EMA mandate process validation for all commercial pharmaceutical products.
Key Points
FDA Guidance: Process Validation: General Principles and Practices
ICH Q7 and EU GMP Annex 15 provide global standards
Validation includes design, qualification, and continued verification
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