Process Validation – Qvents

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Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on August 15, 2024

Updated on August 15, 2024

USFDA: Process Validation: General Principles and Practices – Guidance for Industry
European Medicines Agency (EMA) : Process validation for finished products – information and data to be provided in regulatory submissions – Scientific guideline
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validatio
WHO TRS 1019 – Annex 3: Good manufacturing practices: Guidelines on validation
PICS: Validation Master Plan, Installation And Operational Qualification, Non-Sterile Process Validation, Cleaning Validation
PIC/S: Guide to Good Manufacturing Practice for Medicinal Products Annexes; Annex 15 Qualification and Validation)

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