Good Manufacturing Practices (GMP) are the part of 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 authorization. Part of the Health Products and Food Branch Inspectorate (Inspectorate) program 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 (Part C, Division 2 of the Food and Drugs Regulations) which is a requirement for the issuance of an establishment licence. To ensure a uniform application of these requirements and 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.
Questions? Please contact the Drug Good Manufacturing Practices Unit.