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