Product Quality Reviews
Product Quality Review (PQR) is held with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for starting materials and finished products, to highlight any trends and to identify product and process improvement, if necessary. Zahravi intends to implement PQR for its products according to the established PQR procedures and plan and are include at least:
- A review of critical in-process control and critical API test results;
- A review of all critical deviations or non-conformance and related investigation;
- A review of any change carried out to the processes or analytical methods;
- A review of results of the stability monitoring program; and
- A review of all quality –related returns, complaints and recalls.