PQR is a regulatory requirement (EU-GMP chap 8, US 21 CFR part211, ICHQ7A, GMP for adding the exploitant responsibility) and an effective quality improvement tool to verify annualy the consistency of the existing process & overall quality of the product. These PQRs are assessed deeply by inspectors during Health authorities inspections and should be carefully managed by trained and knowledgeable people.
BlueReg can help you to set up the PQR process in your company and/or manage your annual reviews.
We propose the following approach, to be adapted and designed according to your request.
Setting up and
– Manufacturer PQR
– Local data (ie. variations, deviations, contracts, complaints, recalls)
– Compliance to GMP requirements
– Critical review of batch data evaluation performed by the manufacturer
– Evaluation of the overall quality of the product
– Assessment of the consistency of the existing manufacturing process
– Highlight of any trends
– Review of the proposed CAPAs, highlighting action plans to be monitored or added
– Verification of the consistency between local data and information provided by the manufacturer
|Writing the PQR for the “Exploitant”|
– In accordance with the review template provided by the client or using BlueReg template
– Assessing manufacturer results and setting conclusions on process control
– Providing a global assessment on the local data and the evaluation done by the manufacturer
|QUALITY SYSTEM: BlueReg Internal SOP or Client SOP|