It is imperative that Pharmaceutical companies have a good handle on how to perform Product Quality Reviews (PQR). In fact, effective PQR’s are necessary in demonstrating GMP compliance to regulators such as the TGA and FDA (Annual Product Review).
Product Quality Reviews are a hot topic since being listed on TGA’s Top 10 GMP Deficiencies; key issues being grouping, timely review and data analysis.
Applying appropriate critical analysis and interpretation in your PQR’s will ensure that you don’t neglect potential product quality issues, and also that you limit brand and financial risks to your organisation (with possible product recalls).
To perform effective Product Quality Reviews’s you must be able to:
- Review production records and stability studies
- Identify trends and potential problems
- Summarise the results of the product review
- Be capable of using statistical tools including Cp and CpK, Statistical Process Control (SPC)
- Address microbiological compliance (if required)
- Apply risk management to the PQR process
Contact us if you’d like assistance with understanding how to manage your Product Quality Review process. Or you may be interested in our PQR training.
