What is a GMP environment ?


Quick Answer

Good Manufacturing Practice (GMP) is a system of quality assurance used to ensure that drugs are produced and controlled according to established quality standards. The purpose of GMP is to reduce the risk in pharmaceutical production and conform to guidelines set by regulatory agencies.

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Full Answer

GMP encompasses all aspects of the manufacturing process, from sourcing materials to final production. The guidelines set by GMP are also designed to encourage a consistent standard of training and hygiene across all pharmaceutical organizations. In order to ensure GMP compliance, documented proof must be provided by an organization to indicate the use of correct procedures in each stage of the production process.

In the United States, the GMP is regulated by the Food and Drug Administration (FDA). The GMP includes specific instructions about maintaining quality systems, facilities and equipment systems, materials systems, production systems, packaging and labeling systems, and laboratory control systems.

In Canada, the GMP is regulated by the Health Products and Food Branch Inspectorate program. Inspections are carried out under the Inspectorate program to enforce the guidelines contained in the GMP. All pharmaceutical companies are obligated to undergo inspections in order to be granted a license from the authorities responsible for regulating the GMP standards in Canada.

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