SITE MASTER FILE
What is SMF?
?The Site Master File (SMF) is a document describing the manufacturer's GMP-related activities at a particular site. Moreover, SMF is a document that contains all of the relevant information about a specific site where pharmaceutical products are manufactured, tested, or stored. The SMF serves as a site reference and provides information needed for regulatory inspections, product approvals, and other quality-related activities.
The SMF is prepared by the pharmaceutical manufacturer and should contain specific information about the site's quality management policies and activities, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a site master file needs only to describe those operations, e.g. analysis, packaging, etc.
Which Guidelines to follow for the preparation of SMF?
There are several guidelines that outline the requirements for preparing a site master file, including:
1.??????International Conference on Harmonisation (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (API). This guideline provides guidance on the preparation of a site master file for the manufacture of APIs.
?2.??????European Medicines Agency (EMA) Guideline on the Investigation of Bioequivalence. This guideline provides guidance on the preparation of a site master file for the conduct of bioequivalence studies.
?3.??????World Health Organization (WHO) Good Manufacturing Practices (GMP) for Medicinal Products. This guideline provides general guidance on good manufacturing practices for medicinal products, including the preparation of a site master file.
?4.??????FDA Guidance for Industry: Quality System Regulation - 21 CFR Part 820. This guidance provides guidance on the preparation of a site master file for medical device manufacturers.
?5.??????PIC/S and EU Guideline (Eudralex Volume-4)
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Contents of Site Master File
The SMF should contain at least the following:
1.????General Information
2.????Personnel
3.????Premises and Equipment
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4.????Documentation
5.????Production
6.????Quality Control
7.????Contract Manufacture and Analysis
8.????Distribution, Complaints and Product Recall.
9.????Self-Inspection
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Review Period
Any changes after approval of SMF shall be recorded for keeping a track of changes that have taken place. All such changes shall be collated and amended in the next revision.
Site Master File shall be revised at end of every calendar year or as and when required through change control management system.
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Other Relevant Information
The SMF should provide clear information on the manufacturer’s GMP-related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections.
A site master file should contain adequate information but, as far as possible, not exceed 25-30 A4 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narratives.
The SMF should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The SMF should have an edition number, the date it becomes effective and the review date. It should be subject to regular reviews to ensure that it is up-to-date and representative of current activities. Each appendix can have an individual effective date, allowing for independent updating.