1Material and supplier control
The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.
Inspection Record
Steri-Med Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The company did not justify the hold time for sterilized components, containers, or equipment.
3Other quality system
The written specifications were inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Other quality system
Yields and/or the reconciled quantities were not checked at appropriate stages.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
8Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
9Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
10Deviation, CAPA, and investigation
When the particulate and microbiological limits were exceeded, the company's operating procedures did not prescribe an investigation and implementation of corrective actions. The airborne particle monitoring system was inadequate.
11Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
12Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The company did not set appropriate alert and action limits for the results of particulate and microbiological monitoring.
13Other quality system
The written sanitation program for clean areas was inadequate.
14Other quality system
The written clothing standards for each environmental grade were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-10-18. 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.
