Changes to good manufacturing practices inspection program
Bulletin Published January 5, 2024
Source: Changes to good manufacturing practices inspection program - Canada.ca
Introducing remote inspections during the COVID-19 pandemic
In March 2020, due to the COVID-19 pandemic, Health Canada was unable to conduct on-site good manufacturing practice (GMP) inspections in Canada. As a result, we quickly adopted virtual inspection approaches to maintain regulatory oversight over domestic and foreign pharmaceutical markets.
Throughout the pandemic, we conducted the following types of inspections:
Remote inspections using technology to communicate, share and review documentation without the need for an on-site visit
Hybrid inspections (domestic) using technology to communicate, share and review documentation remotely, with a short on-site visit to evaluate critical aspects that could not be assessed remotely
Hybrid inspections (foreign) consisting of both remote and on-site inspections involving a minimum of 2 regulators inspecting the same site (1 on-site and 1 remotely)
Since the start of the pandemic, we have been looking at the hybrid and remote inspection model. As always, our objective is to ensure that we are efficient, that our inspection program is risk-based and that we provide adequate oversight of regulated parties.
New changes to the inspection program
We will continue to conduct remote inspections of both domestic and foreign GMP inspection programs.
For domestic programs, we may conduct:
follow-up remote inspections to verify that corrective and preventive action (CAPA) plans are in place where we had observed contraventions of the Food and Drugs Act (act) and its regulations
initial remote inspections for drug establishment licence (DEL) applicants seeking authorization to import, distribute or wholesale pharmaceutical drugs
For foreign programs, we may conduct:
follow-up remote inspections to verify that CAPA plans have been implemented in cases where we had observed contraventions of the act and its regulations and on-site verification is not required
remote inspections where there's a critical and immediate need for updated GMP information and an on-site inspection is not feasible
focused remote inspection of a licensable activity where an on-site inspection is not required
In general, we will not routinely conduct hybrid inspections at this time. We will base our decision on whether to conduct a remote, hybrid or on-site inspection on a case-by-case basis.
What to expect during a remote inspection
Our inspector or inspection team will contact your drug establishment to confirm that you can accommodate a remote inspection. This means, for example, you are able to:
screen-share and/or electronically provide documents, including electronic or paper records
screen-share databases or computer systems associated with GMP activities, if applicable
facilitate a remote tour of the facility or areas within the facility, if applicable
accommodate live interviews via videoconferencing with subject matter experts or key staff
Once confirmed, the inspector will send you a request for pre-inspection information. You will provide this information electronically using the agreed-upon electronic sharing platform (such as ePost).
The inspector or inspection team will conduct opening and exit meetings through videoconferencing platforms (such as MS Teams). We may ask for additional information at these meetings.
Throughout the inspection, you may be asked to provide documents electronically or share them during a videoconference.
Contact us
You may email your questions about remote GMP inspections to the Health Product Inspection and Licensing Division: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.