API DMF (Drug Master File) – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

1 minute read Uncategorized

Updated on June 12, 2025

Updated on June 12, 2025

USFDA: Drug Master Files: Guidelines
USFDA: Drug Master File (DMF) Templates
USFDA: Drug Master Files Guidance for Industry: DRAFT GUIDANCE
USFDA: M4: The CTD — Quality Guidance
USFDA: Review of Drug Master Files in Advance of Certain ANDA Submissions
EMA (Europe): Active substance master file procedure – Scientific guideline
EMA: Chemistry of active substances (chemistry of new active substances) – Scientific guideline
EDQM: Guidance for Electronic submissions for Certificates of Suitability (CEP) applications
EDQM / CEP: Certification Policy Documents & Guidelines (CEP: Certification of Suitability to the monographs of the European Pharmacopoeia)
ICH M4 : The Common Technical Document Guidance
WHO: Guidelines on active pharmaceutical ingredient master file procedure (2008)
EDQM / CEP: Content of the dossier for sterile substances, (Draft Guidance – PA/PH/CEP (23) 54, draft 4, May 2024)
Europe CMDh – Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) – Questions & Answers – Active Substance Master File

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