Liberchem Inc. — Health Canada Inspection Findings

Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations

The recorded information or details were inadequate.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The availability, implementation, and/or quality of the written sanitation program 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 temperature and/or humidity control was inadequate.

The written hygiene program was not being followed by plant personnel and/or visitors.

The verification and dispensing of raw materials by qualified staff was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. Critical production processes were not validated. Printed packaging materials were not stored in an area with restricted access. The master formula for packaged products did not include the required information. The master production documents were inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.

The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

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 specifications for raw materials used to produce drugs did not meet pharmacopoeial standards. The standard for purified water used to produce a non-sterile drug was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.