Pharmaceutical companies and in particular small to medium sized ones, are in a perpetual battle to increase efficiency and reduce costs while staying GMP compliant. The always moving landscape of regulatory compliance puts significant demands on the sometimes-limited resources available to these companies. This can result in the prioritisation of activities of seemingly more importance which will inevitably, despite best efforts, lead to the neglect of others.
One activity which often does not get the attention it requires is the Product Quality Review (PQR). Conducting PQRs is a GMP requirement that represents a significant amount of work for any site but particularly those with limited resources e.g. a lack of integrated electronic systems makes data collection cumbersome. A perceived lack of value from the PQR process can promote a view that the PQR is just another report that companies are forced to do to comply with regulations.
However, there are many reasons to give the PQR process more attention. These reasons include:
If the process can be managed to extract sufficient benefit for the effort put in, then the PQR becomes much more than merely a compliance task. Ensuring the maximum value is extracted from each PQR will make the effort worthwhile
If you need help with any aspect of the PQR process from development of suitable procedures to completion of PQR reports please contact email@example.com
Eudralex Volume 4 Chapter 1 ‘Pharmaceutical Quality System’ https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-chap1_2013-01_en.pdf