WHO TRS (Technical Report Series) 961, 2011 Annex 14


WHO TRS (Technical Report Series) 961, 2011 Annex 14

WHO guidelines for drafting a site master file

1. Introduction:

1.1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, 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, an SMF need only describe those operations, e.g. analysis, packaging, etc.

1.2 When submitted to a regulatory authority, the SMF should provide clear information on the manufacturer’s good manufacturing practices (GMP)-related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections.

1.3 An SMF should contain adequate information but, as far as possible, not exceed 25–30 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narratives. The SMF, including appendices, should be readable when printed on A4 paper sheets.

1.4 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 date by which it has to be reviewed. It should be subject to regular review to ensure that it is up to date and representative of current activities. Each annex can have an individual effective date, allowing for independent updating.

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Table of Contents

WHO TRS (Technical Report Series) 961, 2011 Annex 14:

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