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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public Good Manufacturing Practices: The Gap within, Current Regulations and Quality Standards, Current GMP Guidelines (cGMP), The Role of 'c' in cGMP
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Scope and Inportance:
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food; pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
All guidelines follow a few basic principles:
Good Manufacturing Practices (GMP) guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. It should be noted that GMP guidelines do not cover safety aspects for the personnel engaged in the fabrication, packaging/labeling, and testing of APIs and intermediates, or aspects of protection of the environment. These controls are inherent responsibilities of the API fabricator, packager/labeler and tester. The focus of GMP guidelines is on the manufacture of APIs sold in their final labeled container and/or used in the manufacture of finished dosage forms for human use. More specifically, they apply to the fabrication, packaging/labeling, testing, importation, distribution, wholesale, and repackaging/relabeling of APIs (including their intermediates.)
The market research available can provide investors and analyst credible information on the direction of pharmaceuticals and pharmaceutical industry is one of the largest and most advanced among the developing countries and it is 3rd largest pharmaceuticals market by 2020 and the pharmaceuticals industry accounts for about 2.4% of the global pharma industry by value and 10% by volume.
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This page was last updated on 11th Sep, 2015
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