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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.
Good manufacturing practice (GMP) Best practice; American National Standards Institute (ANSI) Institute of Electrical and Electronics Engineers (IEEE) European Medicines Agency (EMEA) Food and Drug Administration (FDA) Ministry of Health, Labour and Welfare (Japan) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation ...
The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an abbreviation for "current good manufacturing practice".
Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
In the US, Good Manufacturing Practice (GMP) Regulations are based on the Code of Federal Regulations 21 CFR 210/211, and USP 1079. The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US ...