TJP Labs Inc. — Health Canada Inspection Findings

Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test. The sampling plan for raw materials was inadequate. A sample from each lot of raw materials was not fully tested against the specifications.

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

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

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging. 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 implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The availability, implementation, and/or quality of the written sanitation program was inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. 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. The training of personnel before new or revised standard operating procedures were implemented was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.

The protection of products and/or materials from contamination was inadequate.

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

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

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.