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