Masterarbeit

Product Quality Review: New requirements related to medicinal products

Dr. Uta Maucher (2009)

Language: English

The product quality review (PQR) is a powerful quality management tool which was added through European legislation. It covers all the aspects of the supply chain from starting materials via processes and process environments to product in order to detect long term trends. It is a complete and in-depth overview of all data related to the pharmaceutical products manufactured and covers a period of 12 months.

In the annual product review it highlights weak and critical items which need adaptation and improvement. However, the intent is not to just list a huge amount of data, but to facilitate an appropriate evaluation, summary and interpretation of that information. It can be used as a tool for continuous improvement and as a consequence may reduce deviations. It also can be a useful tool to improve and control processes and quality and will help to avoid future failures. The product quality review takes advantage of other quality systems already established in the company (change control system, CAPA, deviation…).

The objectives of annual product review (APR) as required by US 21 CFR 211 are similar those of a PQR, but they differ in their requirements. The PQR generally exceeds the requirements of the APR.

The PQR also improves transparency and forces the responsible person to have a critical look at the data. It is an excellent starting point for inspections, because it provides an overview of the products, critical steps and weak points and the focus inside the quality management systems. The PQR gives authorities a detailed look into the whole functionality of the system.

Pages: 31, annexes (1): 24 pages