British Columbia Centre for Disease Control and Prevention Society Branch — Health Canada Inspection Findings

The system for reviewing, revising, and approving standard operating procedures was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. 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.

The written self-inspection procedure was inadequate.

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 written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.