EMA: new Expectations for QPs

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 full contact details of the person through which the audit was arranged should be recorded.
• The dates of the audit should be recorded. A justification should be recorded for the duration of the audit.
• The activities which were not covered by the audit should be clearly recorded.
• If access was denied to any relevant areas of the site this should be recorded and explained.
• Each of the applicable sections of EU GMP Part II should form sections of the report with a summary of what was examined, the key findings and compliance with the requirements of each section.
• A proposed re-assessment period should be recommended.

The new Q&As question the use of one-day audits, especially in cases when less than 8 hours are spent on-site.