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:

  • Lack of attention on PQRs often leads to GMP deficiencies from inspectors

  • Inspectors are increasingly using the PQRs as tools during their inspections. As the PQR can be reflective of the effort put into its preparation it can tell the inspector a lot about the approach to product quality at the site.

  • PQRs should for each product verify the consistency of the existing process, verify the appropriateness of current specifications for both starting materials and finished product, highlight any trends and identify product and process improvements. This should mean:

    • Decreased risk of Out of Specification results
    • Decreased downtime
    • Increased productivity
    • Reduction in rejected product
    • Reduction in recalls
  • The PQR could be used by the QP as part of their product knowledge development.

  • The PQR could be used as a tool during investigations into product related issues.

  • The PQR could be used to document the output of ongoing process verification activity

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 queries@qualityassuredplus.com

Reference:

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

Paul Quinn