JP Laboratories — Health Canada Inspection Findings

The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The training of personnel before new or revised standard operating procedures were implemented was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

Test methods were not validated or the method transfer studies were not conducted.

The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

The electronic system was not validated for its intended use.

The recorded information or details were inadequate.