أنشئ حسابًا أو سجّل الدخول للانضمام إلى مجتمعك المهني.
Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.
Good Manufacturing Practices are practices adopted to ensure quality compliance at every stage of product manufacturing by complying fully all regulations, standards and codes related to specific industry.
The process must be well documented and traceable at all level and times.
This concept has been extended to all fields and industries, for example GLP (Good laboratory practices), GEP (good engineering practices) etc.
Generally this is called GxP.
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line"20 years ago, may be less than adequate by today's standards.
Produce maximum amounts of quality product with minimum raw material, labor costs, overhead costs and with a minimum investment.
Accepting, maintaining, implementing, adhering to the Industrial practices, Government policies, Social requirements, Cultural requirements, Licensing norms and Business ethics, in the manufacturing process. These are very important in food, health care pharmacy products in general to specify for example.
In other cases Eg: Pollution control norms
Practices on how to improve cost, quality and quantity of product and services.
