On April 28, 2020, a message was circulated from Health Canada detailing provisions being put in place in response to the COVID 19 pandemic.
Part of the communication was outlining the plans for the commencement of Sales Inspections. The new approach would be to conduct sales inspections remotely on a risk-based approach and deliver the compliance promotion information presentation to key site individuals.
As this process is new to most of us, I felt it might be useful to share our recent experience.
Our notice of a virtual (off-site) inspection was received Friday for an inspection to take place Monday (9 days later). In addition to the sales inspection notification we received a list of documents requested to be provided by the following Wednesday, and a WebEx appointment for the inspection opening meeting and our mandatory compliance promotion session.
The list of documents required was comprehensive - including site plan, org chart, SOPs and completed records. As the files are quite large, transfer of the documents was by Easy Post. Setting this up was straightforward and the inspectors provided clear instructions.
Three inspectors were assigned to us, unfortunately one was not able to attend, so we proceeded with two inspectors.
The opening meeting was conducted via WebEx on the Monday morning. The format was a standard opening meeting except for a signed attendee register. A virtual site tour was conducted using an overview of the site plan document to identify product and personnel flow.
The following two days consisted of a WebEx batch record reviews, follow up questions and document requests via email or telephone.
Thursday morning was the two-hour mandatory Compliance Promotion session. Then the inspection continued with an off-line document review.
The closing meeting was conducted by WebEx on the Friday. Comments and potential observations were discussed during this meeting to ensure understanding. Health Canada’s standard procedure is to issue an inspection report within 10 business days of the closing meeting.
Our overall impression of the virtual inspections is that it works well for a more document review focused inspection, and I can see how this format might be utilized moving forwards.
Two Tips: -
Make sure you have a well organized document/filing system
Have your experts on standby
Remember Health Canada and License Holders share the same goal – Safe product, proven Quality