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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.

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: ...

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