15/16 February 2022
The European Medicines Agency EMA has published a new set of Question and Answers on their website. A whole set of Q&As is dealing with API supplies and the auditing of the respective sites.
More and more companies use third party services for performing their audits. But how should the audit reports be evaluated and what expectations do inspectors have for the content of reports of audits of active substance manufacturers? In one answer to one of the questions the EMA makes a very clear statement to the role of the Qualified Person, which hasn't been stated in such a clear way yet: "The responsible QP should ensure that he/she or someone to whom it is delegated is in agreement with the overall recommendation of the final report" and "The QP must not release the relevant medicinal products without knowledge of a positive recommendation from the auditor(s)."
The content of the audit report should at least cover the following details:
The new Q&As question the use of one-day audits, especially in cases when less than 8 hours are spent on-site.Source: EMA Questions and answers