The Product Quality Review gets down to business

GMP News No. 896: The Product Quality Review gets down to business

GMP News
1 March 2007

The Product Quality Review gets down to business

Both parts of the EC GMP Guideline recently introduced a powerful quality management tool: the Product Quality Review (PQR). The regulatory authorities expected a first PQR for a minimum review period of at least 6 months in 2006. Nevertheless, until now the PQR was not a big issue in recent inspections.

But this transitional period is over now! The industry is expecting more focus on the PQR in forthcoming inspections. And authorities will more and more use this useful tool for their overall assessment of a company's GMP-compliance. The Irish Medicines Board for example said at their 2005 Pharmaceutical Manufacturing Workshop that actual reviews will not be looked at until 1st January 2007 unless company already has interim/staggered reports.

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; from 26–27 June 2007 in Warsaw, Poland.

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

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