Good Manufacturing Practice (GMP)
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. These regulations require
that manufacturers, processors, and packagers of drugs, medical devices, some
food, and blood and service providers 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 contamination,
mix-ups, and errors. Failure of industries to comply with GMP regulations
can result in very serious consequences including recall, seizure, fines, and
jail terms.
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 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 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,
mix-ups, and errors, which may have been "top-of-the-line" 20 years
ago, may be less than adequate by today's standards. GMP is a good business tool which helps to
refine both compliance and performance at company level.
Main Parameters of GMP
i.Quality Assurance
ii. GMP for pharmaceutical
products
iii. Sanitation and
hygiene
iv. Qualification and
validation
v. Complaints
vi. Product recalls
vii. Contract
Manufacturing and analysis
viii. Self inspection and
quality audits
ix. Personnel
x. Training
xi. Personal hygiene
xii. Premises
xiii. Equipment
xiv. Materials
xv. Documentation
xvi. Good practices in
production
xvii. Good practices in
quality control
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