Site Master File (SMF) – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

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Updated on April 2, 2026

Updated on April 2, 2026

EMA – EU Site Master File (EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines; Part III – GMP related documents)
WHO: TRS 961 – Annex 14: WHO guidelines for drafting a site master file; Guideline
PIC/S: Explanatory Notes For Pharmaceutical Manufacturers On The Preparation Of a Site Master File
SAHPRA (South Africa): Guidelines For Preparation Of Site Master File
TGA (Australia): TGA uses the PIC/S harmonised template for an SMF.

Tags : EMA, PIC-S, SAHPRA, TGA, WHO

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