What is GMP?
GMP stands for Good Manufacturing Practices, which are regulations issued by the India Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. Manufacturers, processors, and packagers of pharmaceuticals, medical devices, some foods, and blood must take proactive actions to guarantee that their goods are safe, pure, and effective, according to these laws, which have the force of law.
GMP requirements necessitate a quality-oriented approach to manufacturing, allowing businesses to reduce or eliminate contamination, mixups, and errors. This safeguards the customer against buying a product that is ineffective or even hazardous. Failure to follow GMP laws can lead to harsh repercussions such as product recalls, seizures, fines, and jail time.
Record keeping, employee qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling are all covered by GMP rules. The majority of GMP regulations are broad and open-ended, allowing each producer to determine how best to execute the required controls. This gives the manufacturer a lot of leeway, but it also means the manufacturer has to interpret the requirements in a way that makes sense for each firm.
GMP is also known as "cGMP" in some cases. The "c" stands for "current," reminding producers that in order to comply with the legislation, they must use up-to-date technology and systems. Systems and equipment used to prevent contamination, mixups, and errors that were excellent 20 years ago may now be considered inadequate by today's standards.