EMA Q&A for Active Substances

Date

April 10, 2025

Category

EU Regulations

Description

The EMA Q&A for EU GMP Pt. II, Active Substances, has just been updated with answers to two new questions:

Q3 - "Is an audit performed by a third party acceptable?”

A3 – The long answer is basically ‘Yes’ providing that the requirements of section 5.27 and chapter 7 of EU GMP Part I are complied with.

MIA holders may rely on audits carried out by active substance manufacturers on their suppliers of active substance intermediates provided that there is an appropriate contractual arrangement in place between the MIA holder and the manufacturer of the active substance.

The answer states that “the MIA holder should ensure that there are arrangements in place to assure that any conflicts of interests are declared, and where declared, that they are assessed for their impact on the impartiality of the audit.”

Q9 - "What are the expectations for the content of written final assessment of third-party audit reports?"

A9 – The answer starts by stating “The QP has the ultimate responsibility to ensure that audit reports are properly evaluated when the audit is performed by a third party.”

The report should include verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs, whether adequate and how these are to be followed up.

The revised Q&A can be found at https://www.ema.europa.eu/en/h... .