1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Contract Pharmaceuticals Limited Canada — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. Critical processes and procedures were not evaluated on a regular basis.
3Material and supplier control
The sampling plan for raw materials was inadequate.
4Other quality system
The implementation of a self-inspection program was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Other quality system
The written hygiene program was inadequate.
7Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
8Equipment and facility
The qualification and/or verification of utilities and/or support systems was inadequate. The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
9Quality unit oversight
The annual product quality review procedure was inadequate.
10Computer system validation
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 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 labelling of outlets for liquids and/or gases was inadequate.
11Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
12Material and supplier control
Printed packaging materials were not stored in an area with restricted access.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-12. 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.
