Patheon Inc. — Health Canada Inspection Findings

The temperature and/or humidity control was inadequate.

The validation and/or the documentation of test methods was inadequate.

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

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The premises were not designed, constructed, operated, and/or maintained to prevent contamination. 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. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

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

Packaging operations were not performed in keeping with the written operating procedures or specifications. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record. Packaging orders did not include the required information. The master production documents were inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

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

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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. The preventative maintenance and repair of the equipment was inadequate.