ENBIS-11 in Coimbra

4 – 8 September 2011 Abstract submission: 1 January – 25 June 2011

Application for Producing Product Quality Review Reports in a Pharmaceutical Company

6 September 2011, 15:45 – 16:05


Submitted by
Heli Rita
Heli Rita and Anni Liimatainen
Orion Pharma
Product quality review (PQR) reports shall be annually compiled for each and every product which is manufactured in a pharmaceutical company. Their purpose is to show that the manufacturing process is stable and capable of constantly producing products which fulfill their quality-related specifications. The reports are based on large amount of data, which usually are stored in several locations in diverse formats. Traditionally, manual gathering of data and editing them for reports has been a huge task, especially in companies with a large product portfolio.

We have installed a product data warehouse for collecting the data related to the manufactured batches in an integrated system. It collects data from an ERP system and from several manufacturing and measurement equipment. These data contain batch-related information e.g. on materials, process parameters, deviations and results of release and in-process tests. The data can be analyzed and reported for several purposes, e.g. for producing the PQR reports. The end-user can utilize the data by web-based applications, which are made available for easy usage via intranet. The applications have been built-up by using stored processes in SAS software.

An application is presented for efficiently producing PQR reports. By using this application, the workload for reporting has changed from manual data gathering to the actual evaluation of products and processes. The content, layout and quality of the about 400 reports annually have become substantially more uniform. Control charts and process capability indices were implemented as a part of reporting in the application, which has induced request of training of SPC methods.

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