Process Validation – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

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Updated on October 11, 2023

Updated on October 11, 2023

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
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

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