1Stability 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.
Inspection Record
Galephar Pharmaceutical Research Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
5Laboratory and QC controls
The validation of test methods was inadequate.
6Material and supplier control
The protection of products and/or materials from contamination was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
10Other quality system
The company's monitoring of water testing was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-01-29. 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.
