Pharmascience Inc. — Health Canada Inspection Findings

Yields and/or the reconciled quantities were not checked at appropriate stages. The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.

The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.

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

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

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

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 evidence required to demonstrate compliance with finished product specifications was inadequate.

The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.

The ongoing stability program for a drug was inadequate.

The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The maintenance of records was inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.

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