1Stability and storage
The ongoing stability program for a drug was inadequate.
Inspection Record
Biolyse Pharma Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Complete confirmatory testing was not conducted on raw materials from each vendor.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The standard operating procedures or records for shipping and receiving raw materials were inadequate.
4Computer system validation
A preventative maintenance system had not been established 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.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
7Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization. The operators'aseptic practices were inadequate to maintain sterility. The condition of the clean area used to produce sterile products was inadequate.
8Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
9Other quality system
The company's visual inspection of filled containers was inadequate.
10Laboratory and QC controls
The validation of test methods was inadequate.
11Laboratory and QC controls
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The validation of test methods was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-04-17. 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.
