Tuesday, February 9, 2016

What is GMP

GMP is that part of Quality Assurance which ensures that the products are consistently manufactured and controlled for the purpose of their intended use or as required by marketing authorization.
This covers all the matters related to the quality and repeatedly ensures that the quality of reliability which is reproducible. It is secured for all the time with an objective of serving the exact needs of the customer and also fulfills the requirements of regulatory agencies around the world.
GMP as per Guidelines
The MCA (UK) states
   GMP is that part of Quality Assurance which ensures that the products are consistently manufactured and controlled for the purpose of their intended use or as required by marketing authorization and product specification.
The MCC (South Africa) states
   GMP is that part of Quality Assurance which ensures that the products are consistently manufactured and controlled for the purpose of their intended use as per legal requirements, marketing authorization and product specification. It also adds that the GMP is thus concerned with both Production and Quality control matters.
Good Manufacturing practice is that part of Quality Assurance which ensures that the products are consistently produced and controlled to Quality Standards appropriate to their intended use and as required by marketing authorization.
GMP is aimed at eliminating inherent risks in any Pharmaceutical production. Such risks are Cross-Contamination (especially from unexpected contaminants) and mix-ups caused by e.g. false labels put on container.
Drugs and Cosmetics rules 1945 published as require by sections 12 and 33 of The Drugs and cosmetics Act 1940.
The Schedule M of the said act talks about Good Manufacturing practices and requirements of premises, plant and equipment for Pharmaceutical products.

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