27/28 October 2021
The Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh) of the Heads of Medicines Agencies has revised its Question and Answers Document on the QP Declaration.
The guidance has been updated to explain the types of QP declarations that must be submitted to support individual changes to marketing authorisation: "Which Qualified Person declaration(s) are required in support of individual types of changes to a Marketing Authorisation, to confirm that the active substance is manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials?"
The answer is given for the different possible changes: API manufacturer, finished product manufacturer and batch release site.
New active substance manufacturer or new site of an already approved site: "QP declarations should be provided from each of the registered finished product manufacturing and batch release sites located in the EU/EEA. The declarations should cover all new intermediate and API manufacturers…".
New finished product manufacturer: "as a minimum QP declarations should be provided from the proposed new finished product manufacturer (if located within EU/EEA), as well as at least one of the registered EU/EEA batch release sites." (…) "A further declaration from the QP responsible for batch certification is expected when the batch release site is a different site from the site which is added with the proposed variation."
New finished product manufacturer which is also responsible for batch release or simultaneous addition of a new finished product manufacturer and a new batch release site: "as a minimum QP declarations should be provided from the new batch release site, as well as the proposed new finished product manufacturer (when located within EU/EEA, if different from the former)."
New batch release site: "a QP declaration should be provided from the proposed new batch release site, covering all registered drug substance manufacturing sites (main and intermediate manufacturing sites)."
In the text, also the following question is answered: Is it acceptable to provide a single declaration signed by one QP (rather than multiple declarations)?
The answer is that this "may be acceptable" if this declaration will be "signed on behalf of all the involved QPs" and supported by a "technical agreement as described in Chapter 7 of the GMP Guide and the QP providing the declaration is the one identified in the agreement as taking specific responsibility for the GMP compliance of the active substance manufacturer(s)."
The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. The revised document CMDh/340/2015, Rev.2 can be found in CMDh Question & Answers.