Good Manufacturing Practices
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.
- Good Manufacturing Practices (GMP) Inspection Summary Reports [2014-07-22]
- Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001) [2011-03-04]
- Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program - April 1, 2006 to March 31, 2011 [2012-12-21]
- Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014) [2011-11-18]
- Letter to Stakeholders - Responsibilities and Obligations with Respect with the Good Manufacturing Practices
- Chemical Entity Products/Quality
- Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers) [2011-07-22]
- Notice - Submission Filing Requirements - Good Manufacturing Practices (GMP)/Establishment Licences (EL)
- Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013
Questions? Please contact the Drug Good Manufacturing Practices Unit.
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