Good Manufacturing Practice (GMP)
Issuing time:2022-09-15 09:44
What is GMP?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followedat each step in the manufacturing process - every time a product is made.
GMP is typically ensured through the effective use of a quality management system (QMS).
Why need GMP?
GMP guidelines require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rulesthat govern each industry may differ significantly; however, the main purpose of GMP isalways to prevent harm from occurring to the end user. Failure of firms to comply withGMP regulations can result in very serious consequences including recall, seizure, fines,and jail time.
GMP guidelines address issues including record keeping, 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 first-rate 20 years ago may be less than adequate by current standards.