Product Quality Review (PQR)


What you will learn

Product Quality Review (PQR), also known as APQR (Annual Product Quality Review) is a regulatory requirement, which requires a legal Applicant to review (and document) the quality aspects of each product yearly. This training module focuses on the local PQR process of imported products. The overseas manufacturing site prepares the main PQR report for these products, and the local Applicant reviews it. Reading and “endorsing” this report is unfortunately not good enough, because it does not ensure that the local requirements were also considered. The aim of this training module is to demonstrate how to conduct a meaningful local PQR review for an imported product. The exercises provide maximum coverage of the learning material, as well as a real PQR report of a fictitious product. We will help you to execute this report step by step. We also give you examples of possible issues that you may encounter during the execution of a local PQR.

Who would benefit from this course?

Pharmacists who work in Industry and need a better understanding of how to execute a
Product Quality Review or need a refresher.

Pharmaceutical support staff who will benefit from a better understanding of the PQR

• It is also ideal as part of a training curriculum for newly appointed staff at a
pharmaceutical company who are responsible for overseeing or assisting with the PQR