Chief Medical Supplies Ltd — Health Canada Inspection Findings

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

Critical production processes were not validated. The protection of products and/or materials from contamination was inadequate.

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

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

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.

Measuring devices were not regularly checked for accuracy and precision. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.

The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards. The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.

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

The validation and/or the documentation of test methods was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.