Delta Pharma Inc. — Health Canada Inspection Findings

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The maintenance of personnel records 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 calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The establishment and/or the maintenance of a data governance plan was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate. The maintenance of records was 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 assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was 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 implementation of a self-inspection program was inadequate.

The quality control department was not involved in all decisions for the quality of the product. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.

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

Investigations into deviations, reports, and/or follow-up actions were inadequate. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.

The system for reviewing, revising, and approving standard operating procedures was inadequate.

The maintenance of the premises was inadequate. The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.