Preparing for Drug Establishment License Inspections
The drug establishment license (DEL) application process in Canada is intimidating for many groups due to the mandatory inspection of facilities by Health Canada. With adequate preparation and understanding of the requirements and necessary documentation, applicants can sail through the inspection with minimal stress and positive results. Health Canada inspectors will assess operations against the standard of Good Manufacturing Practices (GMP) as they are set out in Part C, Division 2 of Health Canada’s Food & Drug Regulations (1). Two guidance documents should be consulted in preparation for inspections; both of these have been updated by Health Canada in 2018.
The Good Manufacturing Practices Guide for Drug Products (2) lists each requirement of the Canadian GMPs and provides an explanation of the criteria for compliance to that section. This guidance document is also conveniently divided into different activities within each section; for example, a fabricator may have a heightened requirement for cleanliness of their premises compared to requirements of a wholesaler or distributor.
The second guidance document, How to Demonstrate Foreign Building Compliance with Drug Good Manufacturing Practices (3) is a good reference document for importers who are required to demonstrate GMP compliance of their foreign suppliers.
Health Canada inspections are required for new DEL applications, and a re-inspection will occur one-year post licensing. After that time, the frequency of inspections depends on the activity that is underway at the facility. For importers and distributors of drug products, inspection cycles are currently at a frequency of every 4 years. Packagers, labellers and testing facilities will undergo inspections every 3 years, and sterile fabricators can expect to undergo Health Canada inspections every 2 years.
Regardless of whether the inspection is for a new or current DEL, the inspection will be broken down by Health Canada into the following phases:
Opening meeting
Tour of the facility
Documentation review (standard operating procedures)
Exit Meeting
Follow-up
During the final follow-up stage applicants will have the opportunity to address the observations noted by the inspector during the audit. The response to each observation should be weighed carefully by the applicant with respect to corrective and preventative actions, and the timelines for these. Applicants should allow sufficient time for implementation of procedural changes rather than make a commitment to Health Canada to implement changes immediately. This will ensure that adequate time has been left for personnel to adjust to any new procedures, and for supply chain partners such as distributors or storage warehouses to adapt to changes such as revised operational procedures.
When preparing for Health Canada inspections, ensure that all standard operating procedures are finalized, approved, and quality agreements with suppliers such as foreign fabricators are current and executed. Any of these documents may be requested by the inspector before coming out to see the facility.
Mock audits are a useful exercise for first-time applicants and can be performed by Canadian regulatory consultants with experience in the area of Canadian Good Manufacturing Practices to increase confidence and reduce the number and severity of observations raised during inspections.
References:
1) Food and Drug Regulations: http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html
2) Good Manufacturing Practices Guide for Drug Products (GUI-0001): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001.html
3) How to Demonstrate Foreign Building Compliance with Drug Good Manufacturing Practices (GUI-0080): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidance-evidence-demonstrate-drug-compliance-foreign-sites-0080/document.html
