Transcription of Site Master File final EU
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Site Master File final EU
1 of 8 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064603 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Explanatory Notes on the preparation of a site Master File These notes are intended to provide guidance on the recommended content of the site Master File. A requirement for a site Master File is referred to in Chapter 4 of the GMP Guide. Status of the document: New Commission Europ enne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium Telephone: (32-2) 299 11 11 1. INTRODUCTION The site Master File 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.
- Toxic or hazardous substances handled (e.g. with high pharmacological activity and/or with sensitising properties); - Product types manufactured in a dedicated facility or on a campaign basis, if applicable; - Process Analytical Technology (PAT) applications, if applicable: general
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