For manufacturers and companies in the pharmaceutical industry, the PQR – Product Quality Review – is a document that must be created annually for all manufactured active pharmaceutical ingredients (API) and finished medicinal products as part of the quality management. As a quality report, it documents that the manufactured products are continuously produced and also checked in accordance with the required quality standards.
Special aspects apply to the preparation of the PQR for contract manufacturing and importation of medicinal products into the European Union. The specific regulations according to Annex 21 of the EU GMP guidelines have been in force since August 2022. For example, there are detailed specifications regarding sampling in non-EU countries or the comparability of analysis data. These aspects, among others, must also be recorded in the PQR.
The aim of the German language online seminar "The Product Quality Review (PQR)", which the Forum Institute is offering on November 20, 2025, is to impart basic and specific knowledge for practical applications.
gempex is contributing to the event with its technical expertise and in-depth practical experience. Dr. Martin Melzer, Principal Consultant at gempex GmbH, will speak on the following topics:
- Fundamentals of PQR
- Objectives
- Requirements and implementation in detail
- Utilization of results
- Special aspects of PQR
- Implementation as a marketing authorization holder
- Involvement of contract manufacturers and active ingredient manufacturers
- EU GMP Annex 21 (importation of medicinal products)
In the subsequent practical workshop, participants will have the opportunity to directly apply what they have learned and address specific questions on the topic.
Other topics covered in the seminar include the regulatory framework - EU GMP guidelines and general requirements - as well as PQR from the perspective of the authorities - expectations, experiences, and typical findings. Registration and further information about the event are available on the website of the organizer, Forum-Institut.
gempex is an expert in the field of inspection-proof, continuous creation of product quality reviews, is familiar with the latest regulatory requirements, and provides companies with expert support in preparing PQRs.
If you have any questions on this topic, please contact Dr. Martin Melzer at contact@gempex.com.
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