Product Quality Review and Annual Product Review

Since 2006, the EU-GMP guidelines are requiring a Product Quality Review (PQR) for active pharmaceutical ingredients (API) and finished products with a marketing authorization. Product quality and process stability must be verified and, where necessary, adjusted using suitable corrective and preventive actions.

The PQR is a life-cycle document, updated annually and kept throughout the product´s entire commercialization phase.

For the US market, an Annual Product Review (APR) must be prepared for API and finished products. The US FDA also requires performance indicators or quality metrics for the assessment, which is not required by EU-GMP guidelines. And more other differences have to be taken into account.

A structured approach has proven to be effective for setting up an efficient PQR/ APR. Core considerations are the following 5 points:

• Target market: Which will be the target market? USA or EU, similarities/ differences
• Parameters: Which parameters should be considered - Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) need to be identified. 
• Management system: Can the necessary facts and figures for the PQR /APR easily be retrieved from the respective management systems and documentation platforms?
• Objectives: What is the key objective of the annual reports?
• Key figures: Which key figures should the annual reports contain?

Dr. Martin Melzer, Principal Consultant of gempex, will speak about this at the Live Online Seminar of Concept Heidelberg:

gempex as the GMP-Expert supports customers in the form of consulting, training or even relief in the daily GMP routine in all tasks related to PQR / APR, change management or CAPA measures.

Dr. Martin Melzer, gempex GmbH, will be happy to answer any questions on this topic:
Martin.Melzer@gempex.com