PLZ Corp. — Health Canada Inspection Findings

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 creation, maintenance, processing, and/or review of laboratory data was inadequate.

The master production documents were inadequate. The recorded information or details were inadequate.

The maintenance of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The written procedures and records for retaining samples were inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The controls put in place for electronic signatures were inadequate.

Validation studies were not conducted in keeping with the predefined protocols.

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 change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The duties of the individual in charge of the quality control department were delegated to an unqualified individual.

The labelling of outlets for liquids and/or gases was inadequate. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.