1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The controls put in place for electronic signatures were inadequate. The maintenance of records was inadequate.
Inspection Record
Canadian National Pharma Group Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Material and supplier control
The specifications for any packaging materials were incomplete or inadequate.
4Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures. The handling of standard operating procedures for good manufacturing practices was inadequate.
5Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Equipment and facility
The training, experience, and/or reporting structure of the individual responsible for packaging operations was inadequate. 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.
8Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
9Laboratory and QC controls
Packaging operations were not performed in keeping with the written operating procedures or specifications. The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
12Training and personnel
The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.
13Computer system validation
The preventative maintenance and repair of the equipment was inadequate. 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.
14Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-01-08. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
