Capcium Inc. — Health Canada Inspection Findings

The effectiveness of the training was not assessed by the firm. The ongoing training of personnel was inadequate.

The qualification and/or verification of utilities and/or support systems was inadequate. The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated. The control of quarantine areas was inadequate. The labelling of outlets for liquids and/or gases was inadequate. The temperature and/or humidity control was inadequate.

The availability, implementation, and/or quality of the written sanitation program was inadequate.

The recorded information or details were inadequate.

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

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

The establishment and/or the maintenance of a data governance plan was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The suitability of the culture media was not verified. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.

Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

The electronic system was not validated for its intended use.