Understanding Annex 15: Qualification and Validation
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….
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