Understanding Annex 15: Qualification and Validation

digi — Wed, 11 Jun 2025 03:50:26 +0000

Understanding Annex 15: Qualification and Validation Demystifying Annex 15: Qualification and Validation Under EU GMP Validation and qualification are foundational pillars of GMP compliance in pharmaceutical manufacturing. Within the European Union, Annex 15 of the EU GMP guidelines provides specific directives for how to perform equipment qualification, process validation, cleaning validation, and computerized system validation....

facility qualification GMP – Pharma GMP

Understanding Annex 15: Qualification and Validation