Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. For the Jurassic 5 album, see Quality Control (album) In engineering and manufacturing, quality control and quality engineering are involved in developing systems to ensure products or services are designed and produced to meet or exceed customer requirements. ... Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ...

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 GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s). A sample is that part of a population which is actually observed. ... A statistic (singular) is the result of applying a statistical algorithm to a set of data. ... Holism (from holon, a Greek word meaning entity) is the idea that the properties of a system cannot be determined or explained by the sum of its components alone. ... In general terms, documentation is any communicable material (such as text, video, audio, etc. ... Traceability refers to the completeness of the information about every step in a process chain. ... A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. ... The Lachine Canal, in Montreal, is badly polluted Pollution is the release of harmful environmental contaminants, or the substances so released. ...

The World Health Organization version

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces more compliance requirements than the WHO GMP, as does the Food and Drug Administration's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", because of the colour of its cover, is officially known as The Rules and Guidance for Pharmaceutical Manufacturers and Distributors. The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that acts as a coordinating authority on international public health. ... This is a list of pharmaceutical and biotech companies that are major manufacturers on global or national markets : Abbott Laboratories Able Laboratories Akzo Nobel Allergan Almirall Prodesfarma Alphapharm Altana (previously Byk Gulden) ALZA, part of Johnson & Johnson Amgen AstraZeneca, formed from the merger of Astra AB and Zeneca Group PLC... hi “FDA” redirects here. ...

Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the US), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines to the manufacture and testing of active raw materials. Year 1999 (MCMXCIX) was a common year starting on Friday (link will display full 1999 Gregorian calendar). ... The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical...

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. Data transfers must be performed in specific ways to avoid mistakes (e.g., writing down a reading on a balance and requiring a second person to also check the balance reading to assure accuracy). Methods have been developed to make this process easier (e.g., links between equipment and central data storage facilities for direct transfer of important data). The movement of data from one location to another is called data transfer. ...

Enforcement

GMPs are enforced in the United States by the FDA; within the European Union, GMP inspections are performed by National Regulatory Agencies (e.g., 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[[1]] and by similar national organisations worldwide). Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly; additionally, many countries perform Pre-Approval Inspections (PAI) for GMP compliance prior to the approval of every new drug for marketing. The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. ... An Inspectorate or Inspectorate-General (or General Inspectorate) is a civilian or military body charged with the mission of inspecting and reporting on some institution or institutions in its field of competence. ...

Regulatory agencies (including the FDA in the US and regulatory agencies in many European nations) are legally entitled to turn up unannounced to conduct inspections, if they believe that there are suitable grounds for doing this.

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 practice' (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans;
• Good Distribution Practice (GDP), for wholesalers and distributors; and
• Good Regulatory Practice (GRP), 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, all of which follow similar philosophies. GLP It is important to be safe when playing in a lab. ... In health care, including medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is the application of the scientific method to human health. ... Toxicology (from the Greek words toxicos and logos [1]) is the study of the adverse effects of chemicals on living organisms [2]. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. ... Pharmacology (in Greek: pharmakon (φάρμακον) meaning drug, and lego (λέγω) to tell (about)) is the study of how substances interact with living organisms to produce a change in function. ... Good clinical practice is a set of rules and regulations that is provided by International Conference on Harmonisation (ICH) - an international body that regulates clinical trials involving human subjects. ... For the record label, see Hospital Records. ... Clinician is a term used generically to describe a wide range of medical professionals See Doctor, Medicine Category: ... Good Distribution Practice or GDP deals with the guidelines for the proper distribution of medicinal products for human use. ... In commerce, a wholesaler buys goods in large quantities from their manufacturers or importers, and then sells smaller quantities to retailers, who in turn sell to the general public. ... The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry. ...

See also

• Food safety
• Good Automated Manufacturing Practice (GAMP)
• Corrective and Preventative Action (CAPA)
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
• Validation (drug manufacture)
• Verification and Validation
• EudraLex