Source of Drug master file

{{Infobox concept | name = Drug master file | subtitle = Regulatory mechanism | Abbreviation = DMF | Contains = Confidential manufacturing and control detail | Referenced by = A customer, with a letter of authorisation | Not = An approval or a certification }} A '''drug master file''' ('''DMF''') is a submission to a medicines regulator containing confidential detail about the manufacture, processing and control of a substance. Its purpose is to allow a customer's application to reference that detail without the holder disclosing it to the customer.{{r|fda_dmf}} A DMF is not an approval. Filing one causes it to be assigned a number and acknowledged; the regulator reviews its content only when an application referencing it is reviewed, and a review finding may be adverse.{{r|fda_dmf}} Equivalent mechanisms exist elsewhere — the European certificate of suitability to the monographs of the European Pharmacopoeia is the closest analogue, though it differs in being an assessment rather than a repository.{{r|edqm_cep}} == How the mechanism works == The holder files the document with the regulator. When a customer submits an application using that substance, the holder issues a letter of authorisation permitting the regulator to review the file in support of that application.{{r|fda_dmf}} The customer never sees the confidential content. This solves a genuine commercial problem: a manufacturer's process is often its principal asset, and disclosure to a customer who may be a competitor's supplier is unattractive. Because review occurs only in the context of an application, an unreferenced file has never been assessed. A statement that a substance "has a DMF" therefore says that a document exists, not that it has been found adequate.{{r|fda_dmf}} == What a DMF claim establishes == | Claim | What it establishes | |---|---| | A DMF has been filed | A document exists with a number | | A DMF has been referenced | A regulator has reviewed it for one application | | A DMF has no outstanding deficiencies | Review occurred and was satisfactory | | Nothing further | The material in a given vial | The last row matters here. A DMF describes a process and its controls for a substance intended as an [[Active pharmaceutical ingredient|active pharmaceutical ingredient]]. Material sold as a research chemical is not that substance in the regulatory sense, even where the chemistry is identical.{{r|ich_q7}} DMF numbers are published in regulator lists, so the existence of a filing is checkable. Its status generally is not.{{r|fda_dmf}} == Relevance to this wiki == Supplier documentation sometimes cites a DMF number as evidence of quality. It is evidence of a filing, which is a real thing and a checkable one, and it is not evidence about a research-chemical lot.{{r|reports}} The general shape is the same as for [[ISO 9001]] and [[Good manufacturing practice|GMP]] claims: each is a genuine and verifiable claim about an organisation or a process, each is checkable with particulars, and none is a statement about the material in a vial.{{r|iso9001}} That is a documentary observation and not an allegation about any organisation.{{r|usp1503}} == References == {{reflist}} <ref name="fda_dmf">United States Food and Drug Administration, ''Drug Master Files: Guidelines'' and the published DMF list.</ref> <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> == See also == * [[Active pharmaceutical ingredient]] * [[Good manufacturing practice]] * [[ISO 9001]] * [[Certificate of analysis]] {{DEFAULTSORT:Drug master file}} [[Category:Drug regulation]] [[Category:Good manufacturing practice]] [[Category:Regulation and law]]