Transcription of Ref. Ares(2014)968076 - 28/03/2014 - European Commission
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Ref. Ares(2014)968076 - 28/03/2014 - European Commission
Ref. Ares(2014)968076 - 28/03/2014 . European Commission . HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Public Health and Risk Assessment medicinal Product quality, safety and efficacy Brussels, 16 August 2013. EudraLex The Rules Governing medicinal Products in the European Union Volume 4. EU Guidelines for Good Manufacturing Practice for medicinal Products for Human and Veterinary Use Part 1. Chapter 2: Personnel Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC.
2 Principle The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the
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