Biolyse Pharma Corporation — Health Canada Inspection Findings

The establishment and/or the maintenance of a data governance plan was inadequate. The maintenance of records was inadequate.

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

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

The design, equipment, and/or maintenance of the testing laboratory was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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

Evaluation of production processes, equipment, and/or materials was inadequate.

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

The quality control department did not undertake all of the required activities. Investigations into deviations, reports, and/or follow-up actions were inadequate.