Health Canada Releases New Guidance on GMP Inspections

Health Canada’s Health Products and Food Branch Inspectorate has issued a revised guidance for drug companies aimed at improving the scheduling of inspections and delivery under the Drug Good Manufacturing Inspection Program.

The final guidance, which took effect Jan. 31, emphasizes that new facilities should be ready for an inspection when they apply for an establishment license and notes that failure to be prepared could cause the application to be withdrawn. If that occurs, the business will have to resubmit its application with all supporting information.

The inspectorate is required to conduct an initial on-site inspection within three months of receiving a license application. That inspection is usually followed by a regular inspection sometime during the next year. Inspections may be unscheduled but generally are announced.

Once an inspection is scheduled, it will take place on the set date unless that date is changed by the inspectorate, the guidance says. Firms requesting a change of date must present sufficient justification.

The guidance can be accessed at www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/pol-0011_gmp_cdn_drug_est_2008-01-31_ltr&doc_e.pdf.