GMP Standards

Good Manufacturing Practices (GMP) are the part of Canadian quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorities under the GMP guide. Part of the Health Products and Food Branch Inspectorate (“Inspectorate”) program in Canada is to conduct inspections of establishments that are involved in activities covered by the Establishment Licensing framework. These inspections are conducted to verify the compliance with GMP, which is a requirement for the issuance of an establishment licence. To ensure a uniform application of these requirements and to help the industry to comply, the Inspectorate has developed the Good Manufacturing Practices Guidelines as well as a series of guides and other related documents.

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