Recently, SCC distributed a survey regarding extraordinary events to all of its recognized GLP facilities. SCC wishes to thank all of the facilities that took the time to complete the survey. The responses received have helped us understand your challenges, and have enabled us, in part, to strategically plan for future inspection activities while minimizing impacts on your organization.
SCC is continuing to monitor the impact of COVID-19 on GLP operations throughout the country. The safety of our staff, contract inspectors, and GLP recognized organizations remains paramount in all decisions being made.
We are a large country with GLP facilities located in most provinces. While travel within Canada is easier than internationally, there are still significant barriers to performing onsite GLP inspections, given the jurisdictional boundaries.
It is important that SCC continues to monitor GLP facilities and fulfill its role as the monitoring authority of Canada. This service allows our Canadian regulators/receiving authorities to continue to have confidence in the data they review. It also allows the data produced in Canada to be accepted internationally in OECD member countries through the Mutual Acceptance of Data (MAD).
Where possible, SCC has decided to perform remote GLP inspections in an effort to continue to provide GLP monitoring services until conditions improve. Efforts will be needed from all organizations to make remote inspections possible.
For those who have a regularly scheduled GLP inspection due in the near future, SCC will be contacting your organization to fill in a remote inspection feasibility review form. This will help us to determine if a remote inspection is possible.
- If a remote inspection is performed, an onsite inspection will then be scheduled once the normal monitoring program resumes.
SCC understands the challenges that GLP facilities may now be facing; however, facilities must continue to maintain GLP compliance.
- If a remote inspection is not considered possible the inspection will be deferred to a later date. This delay may also lead to suspension of recognition or removal from the program if the delays are significant.
As the situation continues to evolve our guidance may change. SCC will provide further information as it becomes available.
To be implemented immediately.
Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at firstname.lastname@example.org or +1 613 238 3222 ext. 443 for more information.