Drug Establishment Licensing
Companies that fabricate, package, label, distribute, import, wholesale and/or test drugs require a Drug Establishment Licence under Division 2 of the Food and Drug Regulations.
Issued by the Health Products and Food Branch of Health Canada, a Drug Establishment Licence authorizes the Canadian licensee to fabricate, package, label, distribute, import, wholesale and/or test a drug. This signifies Good Manufacturing Practice (GMP) compliance and helps ensure that the Canadian pharmaceutical market consists of safe and high quality drug products.
An establishment’s Standard Operating Procedures (SOPs), associated documentation and the facility itself are assessed against the drug’s GMPs as part of the inspection and licensing review. Appropriate standards and practices with respect to premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control, packaging, material testing, finished product testing, records, samples, stability and sterile products, where applicable, should be in place.
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