1Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The temperature and/or humidity control was inadequate.
Inspection Record
TJP Labs Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
3Material and supplier control
The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions.
4Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The availability, implementation, and/or quality of the written sanitation program was inadequate.
5Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
6Stability and storage
The temperature and/or humidity control was inadequate. The design of the drug stability study was inadequate and/or not justified with a documented rationale.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-18. 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.
