The Product Quality Review in the Focus of Inspections

GMP News No. 936: The Product Quality Review in the Focus of Inspections

GMP News
3 May 2007
 

The Product Quality Review in the Focus of Inspections

 
Both parts of the EU GMP Guideline introduced a powerful quality management tool: the Product Quality Review (PQR). After a transitional period, the PQR is getting more and more important in recent inspections.

In a GMP-Symposium held by the Inspectorate Darmstadt, Germany, it was emphasised that the Product Quality Review "is a must" (Rudolf Völler, 16.11.2006).

In another example, the Irish Medicines Board said at their 2005 Pharmaceutical Manufacturing Workshop that actual reviews will be looked after 1st January 2007.

But also members of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), like the Health Science Authority of Singapore have adapted the PQR. In their Guidance Notes on Product Quality Review, the authority states that the "Product Quality Review is an important aspect of Good Manufacturing Practice" and that it is important for manufacturers and marketing authorization holders to conduct this review.

In their revised GMP Guideline 2007 Edition (GUIDE-0001), which has been published for comments, Health Canada has added a whole new chapter dealing with an Annual Product Quality Review.

By the way: the FDA issued two Warning Letters in the fiscal year 2006 for failure to establish the Annual Product Review.
  

Learn more about the regulatory requirements and how to implement and improve your PQR in the following ECA course:

Product Quality Review – compliant, reasonable, efficient; 26 – 27 June 2007, Warsaw, Poland

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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