European QP Association Developments January through April 2025
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Board Developments and Resolutions
A current topic of the Engagement Board: Sharing and Delegating QP responsibilities. The outcome will lead to a parallel Session at the QP Forum in November.
Surveys
Survey on Drug Shortages
Marketing Authorization Holders will soon become responsible not only to deliver their products, inform on any upcoming difficulties to continuous supply in a timely manner, but also to maintain and share shortage prevention plans and shortage mitigation plans on each of the authorized products. Such plans are supposed to be subject to inspections.
With this survey, EQPA asked how QPs are currently involved in these developments and where they would define their future role in drug shortages. The results may be shared with the inspectors working group as appropriate.
Comments on Veterinary Medicinal Products Regulations
The European Commission had published two drafts of implementing regulations on veterinary medicinal products for public consultation with a very short notice. EQPA as a nominated interested party provided comments to the published draft. Comments can be found on website of the EU Commission:
- Comments on "Veterinary medicines - rules on good manufacturing practices for active substances used as starting materials"
- Comments on "Veterinary medicines - rules on good manufacturing practices"
Q&As on Third Party Audits
EQPA and ECA have been involved in a dedicated stakeholder review for three Q&As related to audits on API manufacturers and how to refer to these audit reports in the QP declaration template. Two of the Q&As have been published: one as Q&As on GMP and one as Q&As on the QP declaration template for marketed products.
Although general principles applicable to any kind of audits are discussed on how to outsource (contract) and rely on third party audits and selected auditors (assessments), the Q&As are specifically elaborated for audits at API manufacturing sites referred to in QP declarations for marketed products (H+V). The same is true for the Q&As regarding the QP declaration, which could be easily applied without any modification to QP declarations for IMPs but is now only published for the QP declaration on marketed products. EQPA considers these Q&As may have significant impact on the current approaches followed by QPs and their (global) organizations on audits and auditing under the responsibility of MIAHs.
Miscellaneous
Validity of GMP Certificates - EQPA Letter to EMA
In the regular exchange between GMDP inspectors working group (IWG) with interested parties including ECA/EQPA, a letter was sent to IWG in October 2024 seeking for advice on the risk of expired GMP certificates in 2025 if no automatic prolongation nor a replacement based on a new inspection would happen. IWG has assessed the situation and responded on 9 December 2024. Within the response two specific responsibilities related to GMP certificates have been assigned personally to the QP. EQPA expressed its disagreement to such assignment by a response on 17 December 2024 and on 9 January 2025. Both communications are available in the news section.
Events
This year's QP Forum (the 20th!) will be held 27/28 November 2025 in Barcelona. A lot of hot topics for QPs have been identified and will be discussed in the various presentations and a lot of hot topics for QPs will be discussed in the various presentations and interactive sessions.
Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 26 November: Investigational Medicinal Products, QP-Leadership with Impact and one on AI Implementation.