North American Institute of Medicinal Plants — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations

The establishment and/or the maintenance of a data governance plan was inadequate. The quality control department did not undertake all of the required activities.

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

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

The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The temperature and/or humidity control was inadequate.

Validation studies were not conducted in keeping with the predefined protocols.

The ongoing training of personnel was inadequate. The training of personnel before new or revised standard operating procedures were implemented was inadequate. The maintenance of personnel records was inadequate.