What is GMP?
What is Good Manufacturing Practice?

 

Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). The term "current" Good Manufacturing Practices or "cGMPs" refers the way the pharmaceutical product regulations are called in U.S. in order to emphasize that the expectations are dynamic. 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 production 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 is considered contaminated (in the US considered adulterated).

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; while 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 referred to as "The Orange Book" due to the colour of the cover. 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 ensure several key attributes: including correctness and legibility. Transferring data must be done in specific ways to avoid mistakes - such as writing down a reading on a balance, this requires that a second person also check the balance reading. 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 GMP is enforced in the US by the FDA (Food and Drug Administration) and in the UK by the MHRA who carry out routine inspections to ensure that drug products are produced safely and correctly. Such inspections often take place when a new drug product is released. In the US the FDA will often turn up unannounced to conduct these inspections. [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. Collectively these 'Good Practice' requirements, and others not mentioned here, are referred to as 'GxP' requirements, and all follow similar philosophies.