Transcription of Site Master File final EU
{{id}} {{{paragraph}}}
Example: barber
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.
showing the room classification and pressure differentials between adjoining areas and indicating the production activities (i.e. compounding, filling, storage, packaging, etc.) in the rooms.; - Lay-outs of warehouses and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitising materials
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: