Good Manufacturing Practice EU-GMP

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). 

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

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. 

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... 

Good Manufacturing Practice (GMP) EU (1991) That part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. 

EU GMP. Good Manufacturing Practice for Medicinal Products in the European Community, Annex 11 Computerized Systems. January 1992. 

Good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) guidelines of the EU were issued uid the drug approval application format Wcis harmonized with the EU Notice for Applicants. 

Canada also initialed a Mutual Recognition Agreement with the EU covering good manufacturing practice (GMP) audits. Accordingly, once the equivalency of the Canadian and European GMP audit procedures have been established, products can enter the respective markets without the need of mutual inspections of the producing facilities in each other s territories. 

The abbreviations GMP and GLP have already been used in various parts of this book. Both of these concepts originated in the United States. The fundamental rules for the preparation of medicaments and the guarantee of their quality lie behind the letters GMP (Good Manufacturing Practice). The fundamental principles are summarized and explained in EU Guidelines on Good Manufacturing Practice for Medicaments [130]. 

European Commission. 1998. EC GMP guide to good manufacturing practice. Revised Annex 1 Manufacture of sterile medicinal products. In The rules governing medicinal products in the EU. Vol. 4 Good Manufacturing Practices. Luxembourg European Commission. 

European Commission. Eudralex Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use - Annex 1 Manufacture of Sterile Medicinal Products. http //ec.europa.eu/health/files/eudralex/vol-4/2008 ll 25 gmp-anl en.pdf Accessed 14 July 2014... 

EU GMP Chap. 1 on Pharmaceutical Quality System highlights the inter-relation of the basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management and emphasises their fundamental importance to the production and control of medicinal products. 

Anonymus, Good Manufacturing Practice (GMP) guidelines, http // ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4 en.htm. Accessed 15 July 2013... 

European Directive 2001/83/EC [7], as amended, states that the QP in the pharmaceutical industry has the responsibility for ensuring that a particular batch has been manufactured in accordance with its marketing authorisation, EU Good Manufacturing Practice (GMP) and equivalent regulations. Other tasks are ... 

The rules governing medicinal products in the European Union. EU Legislation - Eudralex -Volume 4 Good manufacturing practice (GMP) Guidelines. Annex I. Manufacture of sterile medicinal products. March 2009. http //ec.europa.eu/health/documents/ eudralex/vol-4/index en. htm... 

European Commission. Eudralex volume 4 EU guidelines to good manufacturing practice medicinal products for human and veterinary use - Chapter 5 Production. 2014, pp 1-11. ht //ec.europa. eu/health/files/eudralex/vol-4/2014-08 gmp chap5.pdf. Accessed 4 Sept 2014... 

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