Groupe Dissan Inc. — Health Canada Inspection Findings

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. The quality control department did not undertake all of the required activities.

The electronic system was not validated for its intended use.

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

The recorded information or details were inadequate. The maintenance of records was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

The annual product quality review procedure was inadequate.

The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

There was no person on site and/or fully available to the quality control department who was responsible for making decisions for the quality control requirements.

The temperature and/or humidity control was inadequate.

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

The ongoing stability program for a drug was inadequate.

Investigations into deviations, reports, and/or follow-up actions were 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 job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel before new or revised standard operating procedures were implemented was inadequate.