Product Quality Review (PQR) is a mechanism to ensure the data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment.
PQRs are designed for the purpose of identifying and implementing recommendations for required improvements.
The objectives of a PQR are to:
- Verify the consistency of the existing manufacturing process
- Verify the appropriateness of current specifications for both starting materials and finished products
- Highlight any adverse quality trends
- Identify product and process improvements.
Application of PQRs
PQRs provide:
- Useful information and additional controls over manufacturing processes and quality requirements
- Important information for release for supply (RFS) authorised persons
- TGA inspectors will review evidence that a manufacturer has undertaken theirresponsibilities in regard to PQRs, as specified in the GMP or technical agreement.
- The PQRs are inspected at TGA inspections of a manufacturer that conducts release for supply. TGA inspectors will be checking that the PQRs have been conducted in a timely manner.
Manufacturers should:
- Document issues identified through the PQR in a corrective and preventive action (CAPA) and consider the need for revalidation.
- Have a management procedure in place to monitor any CAPAs and revalidations resulting from PQRs.
- Cover PQRs and the effectiveness of the system in internal audits.
- There should be standard operating procedures (SOPs) for ongoing management and review of PQRs.
- The effectiveness of these procedures should be verified during self-inspection.
References
- TGA
- PIC/S
