Introduction
Introduction(07/02/2011)Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medic
Part I - Basic Requirements For Medicinal Products
Chapter 1 - Pharmaceutical Quality System(into operation since 31 January 2013)Chapter 2 - Personnel(into operation since 16 February 2014)Chapter 3 - Premise and Equipment (into operation since 1 March 2015)Chapter 4 - Documentation(January 2011)
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Part III - GMP Related Documents
Site Master FileQ9 Quality Risk ManagementQ10 Note for Guidance on Pharmaceutical Quality SystemMRA Batch Certificate
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Other Documents Related to GMP and GDP
Compilation of Union Procedures on Inspections and Exchange of InformationA revised version of the "Guidelines on Good Distribution Practice of Medicinal Products for Human Use"was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23