The APQR review “à la française”

What is an APQR?

Both US and EU Good Manufacturing Practices (GMP) require manufacturers of all authorized medicinal products to perform Annual Product Quality Reviews (APQR in the US, PQR in EU). These reviews are conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements. Such reviews are conducted and documented annually, (taking into account previous reviews), and include a number of review areas.

The Qualified Person is responsible for ensuring that each single batch is manufactured and controlled in compliance with the applicable regulation, in accordance with MA specifications and GMP, and is responsible for the APQR.

What’s special in France?

As it is the case everywhere, APQR duties involve the manufacturer and the MA Holder. But in France, there is another party involved, the Exploitant (see related article “The mysterious thing that an Exploitant is”). The Exploitant can sometimes be the MAH.

Moreover, French GMP specify that when the manufacturer, the MAH and the Exploitant are distinct, all of them are individually responsible for assessing the results of the APQR and evaluating the need to implement corrective and/or preventive actions or to perform any revalidation.

When the MAH is not the manufacturer and/or the Exploitant, contracts/Quality Agreements must be in place to define each party’s responsibilities in performing APQRs.

So, although mainly the manufacturer and the MAH are involved in performing the APQR, all parties including the Exploitant share responsibilities in reviewing the APQR. This means, for every single product exploited, that the APQR has to be received and checked by the Exploitant. This review has to be a critical review, and has to be documented in order to show that the Exploitant is continuously aware of the quality of the product, and is able to challenge the processes in case of any trend is identified.

APQR review is particularly critical as it is highly challenged by ANSM during routine inspections (both in the content and timelines of the review).It is therefore crucial for an Exploitant to have an effective APQR review process in place.

ATESSIA has a dedicated team performing APQR reviews that meet ANSM’s expectations and can help you in getting it right!

Article written by Raphaël DAUVERGNE, Regulatory and Pharmaceutical Affairs Advisors