European QP Association Survey on the Certification of Batches with GMP Issues

Recommendation

7/8 May 2024

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Currently there is a discussion ongoing about the optimum approach to manage certain situations when an inspection concludes that a manufacturing site does not comply with GMP (and therefore a statement of GMP non-compliance should be uploaded into the EudraGMDP database).

The situations in question are when measures taken to remove affected products from the market or prevent further release to the market in response to the non-compliance lead to a shortage of "critical" medicines, and, when a risk-benefit evaluation that takes account of the details of the non-compliance concludes that patients should continue to receive the medicines in question.

To ascertain the information required by QPs to allow release of medicinal products impacted by a statement of non-compliance, the European QP Association (EQPA) perfomed a survey among its members. This survey was sent out in March to close to 1.800 QP Association members.

Altogether 413 members provided feedback.

Almost half of the respondents (44%) would be prepared to certify a batch, although a GMP Non-Compliance Statement was uploaded in EudraGMDP for one of the sites in the manufacturing chain of a medicinal product, to avoid a shortage of this medicinal product. Even more (60%) would do so if the product in question was critical*. However more than 90% think they would need to contact the authorities before certifying the batch. More details of the survey and the results can be found in the member's area of the EQPA website.

*When defining a product as critical, two criteria were defined which need to be considered: therapeutic use and availability of alternatives.
A. Therapeutic use:
The medicinal product is an integral part of the treatment for a disease, which is life-threatening or irreversibly progressive, or without which the patient could be severely harmed. This could be in acute situations (e.g. emergency situations), or chronic situations/maintenance of stable conditions, or disease with a fatal outcome where the product has been shown to affect the progression of the disease or survival.
B. Availability of alternatives:
Even if the product would be used in the situation defined above, it would not be classified as being critical in case appropriate alternatives are available.