European Good Manufacturing Practice

The basic legislation is compiled in a series of guidelines that are published in Volume 2 till Volume 10. Volume 4 is about guidelines for good manufacturing practices for medicinal products for human and veterinary use, which is also known as European Good Manufacturing Practices (EU GMP). 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

The European regulations relating to dmg GMPs are set out in two directives Directive 2003/94/EC, which lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 

The Rules Governing Medicinal Products in the European Union, Volume 4, Medicinal Products for Human and Veterinary Use Good Manufacturing Practice. 

Good manufacturing practice for medicinal products in the European Community. Brussels, Commission of the European Communities, 1992. 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

Chemical and pharmaceutical manufacturers must establish their own internal reference materials, when no pharmacopoeial monograph exists, to satisfy the requirements of Good Manufacturing Practice (European Commission 1997). 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

Good Manufacturing Practice for Medical Products, European Community, 1992. 

The production of drug products (medicinal products) in the European Union (EU) is controlled under Directive 2001/83/EC of the European parliament and of the Council, which states that the holder of a manufacturing authorization for medicinal products is obliged to comply with good manufacturing practices as laid down by European Community law [13]. The principles and guidelines of GMP for medicinal products are stated by the Commission directive 2003/94/EC, which provides the... 

Anonymous (2005), EU guidelines to good manufacturing practice, in The Rules Governing Medicinal Products in the European Union, Vol. 4, European Commission Enterprise and Industry Directorate-General, available http //pharmacos.eudra.org/F2/eudralex/ vol-4/home.htm. 

European Medicines Evaluation Agency (EMEA) (2003), Good Manufacturing Practices, Chapter 4 Building and facilities, EMEA. 

---