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.
1.4 The Site Master File should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The Site ... manufactured for any clinical trials on the site, and when different from the commercial manufacturing, information of ... 6.2 Process validation - Brief description of general ...
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