Product Quality Reviews (PQRs) are used to:
- verify the consistency of the current manufacturing process
- verify the appropriateness of current specifications (starting materials and finished product)
- identify trends and opportunities for improvement
PQRs are important in process and product control, providing useful information for the quality unit and in particular the Authorised Persons responsible for Release For Supply. As such, GMP inspectors from the TGA, Medsafe and other regulatory bodies will review the Product Quality Review process and documents as part of a GMP inspection.
Your PQRs contain a lot of data, but are you applying appropriate critical analysis and interpretation of the findings to deliver value to your company and ensure GMP compliance?
Without appropriate analysis and interpretation, Product Quality Reviews can be a financial burden on your organisation or, worse still, mask a potential product quality problem.
Our training can help by providing you with the guidelines, tools and procedures to conduct effective Product Quality Reviews which will support GMP compliance and improve the quality of the decision making in your organisation. This course will help you determine the adequacy of the manufacturing controls and product specifications you have in place. The training will address:
- PQR procedures, documentation and records
- How to review production records and stability studies
- Identifying trends and potential problems
- How to summarise the results of the product review
- Use of statistical tools including Cp and CpK, Statistical Process Control (SPC)
- How to address microbiological compliance
- The PQR report
- How to prepare a presentation to key management personnel
- Application of risk management to the PQR process
- Requirements for listed complementary medicines
This course has been designed for all those who are involved in gathering, analysing or interpreting Product Quality Review data. It will be beneficial to those new to the PQR process, as well as more experienced professionals and Authorised Persons.
Format and Course Length:
The 1-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Contact us and register your interest in a public session or having this course delivered on-site.