Q&A Document on QP Declaration updated
Recommendation

19-21 May 2026
Barcelona, Spain
Leadership with Impact”
The joint Q&A of CMDh and CMDv on the QP Declaration has been updated and was now published a revision 8 (CMDh/340/2015/Rev.8).
The answer (Verterinary) to question 7 was updated, with the subtraction of the final paragraph:
"In addition, it should be noted that in accordance with the requirements of VRA E.II.1 and CMDv's published Q&As on variations (specifically 2.11 and 2.12), it is also possible, as a means of "otherwise transmitted", to include any new QP declaration(s), which reflect the positive outcomes of any new site audits as part of any one of these chapter F variations and this approach is encouraged. In these cases, no separate variation application for the change in the audit date has to be submitted. However, the change has to be clearly mentioned in the scope of the application form as well as under "present/proposed". [deleted]
Other updates and additions from the previous version are highlighted in red throughout this document.
Related GMP News
15.04.2026ICH Q9 Training Package updated
01.04.2026New EMA GMP Guidelines in the next three Years
01.04.2026New EMA Guidance: Risk Management for Elemental Impurities in Veterinary Medicinal Products
18.03.2026Sampling in the Focus of the FDA
11.03.2026EU Pharma Package: Final Texts officially published
11.03.2026FDA Guidance Plans for 2026
