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AP
Product Quality Review verifies the consistency and capability of production processes to deliver safe and effective drug products. PQR requirements are described in the Guide to Good Manufacturing Practice for medicinal products (part I and II, PIC/S document PE 009 respectively Eudralex volume 4).
All topics listed in the Guide to GMP must be covered in the PQR. The PQR has the objective to highlight any adverse trends and to identify any necessity for product or process improvements.
Product Quality Review is an effective quality improvement tool that provides useful information and additional controls of the manufacturing process and quality requirements.
Marketing Authorization Holder:
AP
Product Quality Review Evaluation; Marketing Authorization Holder Specific Evaluation and Project Coordination:
- We evaluate PQRs (Product Quality Reviews); APRs (Annual Product Reviews) and the marketing authorization holder specific data according to the GMP Guidelines and your internal requirements within the deadlines you set.
- We compare the content to ensure compliance and timeliness of information held by the marketing authorization holder and manufacturer.
- We provide you with feedback related to discrepancies and PQR deficiencies in a timely manner.
- We coordinate the complete PQR activities.
Our team has conducted thousands of Product Quality Reviews and Marketing Authorization Holder specific evaluations.
Manufacturer:
AP
You need support in the preparation of PQRs, we can help you.
With access to your data, we at Alpinapharm collect all the necessary information within the relevant reporting period and establish a PQR for you which addresses all the required topics according to the GMP guidelines.