EGS EuroCam — Health Canada Inspection Findings

The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated. The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products. The maintenance of the premises was inadequate. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.

The temperature and/or humidity control was inadequate.

The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position.

The validation and/or the documentation of test methods 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. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The availability, implementation, and/or quality of the written sanitation program was inadequate.

The protection of products and/or materials from contamination was inadequate. The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.

The computerized system used to manage product inventory and distribution records to support recalls was not validated. The written procedures for recalls were inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The assessment to release finished products was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. 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. Measuring devices were not regularly checked for accuracy and precision.

The implementation of a self-inspection program was inadequate.

The qualification and/or verification of utilities and/or support systems was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate. The handling of rejected materials and products was inadequate. The master formulas to control the manufacturing process were inadequate. The protection of products and/or materials from contamination was inadequate.

The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The sampling plan for raw materials was inadequate. The recorded information or details were inadequate.