1Equipment and facility
The maintenance of records was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records 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
2Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
3Material and supplier control
The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products. The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated. The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
4Laboratory and QC controls
The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position. The quality control department did not undertake all of the required activities. The implementation and/or maintenance of the quality management system was inadequate.
5Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The availability, implementation, and/or quality of the written sanitation program was inadequate.
6Stability and storage
The temperature and/or humidity control was inadequate.
7Other quality system
The written procedures and records for retaining samples were inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
9Other quality system
Lots or batches of finished product did not comply with the specifications and were made available for further fabrication or sale. The written specifications were inadequate.
10Documentation and records
As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record. Specific identity testing was not conducted on all lots of raw materials received on the premises. Printed packaging materials were not stored in an area with restricted access.
11Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
12Other quality system
The assessment to release finished products was inadequate.
13Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-02. 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.
