European Union Good Manufacturing Practice

EC (1998a), The Rules Governing Medicinal Products in the European Union, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, vol. 4, Eudralex. Available at http //pharmacos.eudra.org/F2/eudralex/vol-4/home. htm (accessed October 2006). 

Council of Europe (2005) European pharmacopeia, 5th edn. Maisonneuve, Paris European Economic Community (1997) Pharmaceutical legislation for medicinal products for human and veterinary use in the European Union. Good manufacturing practices. (Directive 91/ 356/EEC). Eudralex, vol. IV. European Economic Community, Luxemboiug European Economic Community (1998) Notice to applicants for marketing authorization for medicinal products for human use in the Eiuopean Union, Volume IIA (III/3567/92)... 

Council of Europe (2005) European pharmacopoeia 5.0. Maisonneuve, Sainte-Ruffme European Commission (1997) Pharmaceutical legislation - Eudralex - the rules governing medicinal products in the European Union. Good manufacturing practices, vol. 

FDA, Current Good Manufacturing Practices for Finished Pharmaceutical Products 21 CFR 211.25(a). European Union Food Manufacturing Practice for Pharmaceuticals, Medicines Controls Agency, 1997. David Begg Associates (2002), Computers and Automated Systems Quality and Compliance, June,... 

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

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. 

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... 

In the European Union, the Directive 91/356 EEC provides the principles and guidelines of Good Manufacturing Practice (GMP). In a series of Annexes, supplementary guidelines are covered [2.15.1]. 

European Union (2002), Guide to Good Manufacturing Practice for EU Directive 2001/83/EC, Community Code Relating to Medicinal Products for Human Use, Volume 4. 

European Union Guide to Directive 91/356/EEC (1991), European Commission Directive Laying Down the Principles of Good Manufacturing Practice for Medicinal Products for Human Use. 

European Union requirements for blood establishments are to be found in the Guide to Good Manufacturing Practice for Medicinal Products ... 

European Union Guide to Good Manufacturing Practice Annex 1 on the Manufacture of Sterile Medicinal Products European Commission, 1996.. 

A more recent OECD consensus paper [5] requires the development of software in a quality system environment There should be adequate documentation that each system was developed in a controlled manner and preferably to recognized quality and technical standards (e.g. ISO 9001) Similarly the European Union requires in Annex 11 of the EC guide to good manufacturing practice (GMP) for medicinal products [6] The user shall ensure that software has been produced in accordance with a system of quality assurance . 

---