Good Manufacturing Practice (GMP)

Good Manufacturing Practice
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Good Manufacturing Practice' is a set of regulations, codes, and guidelines for the manufacture of drug substances (also known as active pharmaceutical ingredients (APIs)) and drug products (known as medicinal products in Europe), medical devices, in vivo and in vitro diagnostic products, and foods. In the United States GMPs are referred to as "cGMPs" or "current Good Manufacturing Practices" GMP is a term that is recognised worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products.
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product does not meet the required specification and is considered contaminated (in the US considered adulterated). Additionally it is a GMP requirement that all manufacturing and testing equipment and utilities have been qualified as suitable for use; and that all operational methodologies and procedures (such as manufacturing, cleaning, and analaytical testing) utilized in the drug process have been validated to demonstrate that they can perform the activities they purport to, according to predetermined specifications.

[edit] The World Health Organization (WHO) version
The World Health Organization (WHO) version of GMPs is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. In the European Union, the EU-GMPs, with more compliance requirements than those stated in the WHO GMPs are in force; in the USA, FDA's version of GMPs, including requirements over and above those stated in the WHO document, are enforced. Similar forms of GMP are used in other countries, with Australia, Canada, Japan, Singapore and others having highy developed/sophisticated GMP requirements. In the UK the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Book" (because of the colour of its cover) [Officially known as "The Rules and Guidance for Pharmaceutical Manufacturers and Distributors"].
Since the publication in 1999 by the International Conference on Harmonization (ICH) of "GMPs for Active Pharmaceutical Ingredients", GMPs also apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the USA) and other countries who adopt ICH Guidelines (e.g. Australia, Canada, Singapore) to the manufacture and testing of active raw materials.
GMP is designed to help assure the quality of drug products by ensuring several key attributes: including correctness and legibility of recorded manufacturing and control documentation. Transferring data must be done in specific ways to avoid mistakes - such as writing down a reading on a balance, requiring a second person to also check the balance reading to assure accuracy. Methods have been developed to make this process easier - such as links between equipment and central data storage facilities for direct transfer of important data.

[edit] Enforcement
GMPs are enforced in the United States by the FDA (Food and Drug Administration); in the European Union, National Regulatory Agencies perform GMP inspections - for example GMP inspections are performed in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA); in Australia by the Therapeutical Goods Administration (TGA); in India by the Ministry of Health; and by similar national organizations worldwide. Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly, and additionally many countries perform Pre-Approval Inspections (PAI) for GMP compliance prior to the approval of every new drug for marketing.
Regulatory agencies, including the US FDA and many of the European regulatory agencies, are legally entitled to turn up unannounced to conduct inspections, if they believe that there are suitable grounds for doing this.

[edit] Other Good Practices
Other 'Good Practice' systems, along the same lines as GMP, exist: "Good Laboratory Practice" (GLP) for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals); "Good Clinical Practices" (GCP) for hospitals and clinicians conducting clinical studies on new drugs in humans; "Good Distribution Practices" (GDP) for wholesalers and distributors, and GRP Good Regulatory Practice for the management of regulatory commitments, procedures and documentation.
Collectively these 'Good Practice' requirements, and others not mentioned here, are referred to as 'GxP' requirements, and all follow similar philosophies.