GMP News No. 760
GMP News 14 July 2006 |
Qualified Person Must Confirm |
This guideline generally regulates the categorisation of changes (Type IA, IB or II) in the manufacture of medicinal products compared to the specifications in the marketing dossier and the scope of documentation that has to be handed in when these changes are reported to the European registration authority. A new feature of the revised guideline is the requirement that the QP of a marketing authorisation holder must confirm that each API supplier indicated in the marketing dossier has manufactured the API in compliance with GMP, i.e. Part II of the EU-GMP Guide (ICH Q7A). Should several QPs be involved in the production process, it is sufficient to have the confirmation of the QP who has overall responsibility for the batch and who provides the final signature, thus certifying the batch. In case of the following variations (changes) with regard to the marketing dossier, this confirmation by the QP will be required in the future:
These additional requirements in the revised guideline consistently bridge the gap to Directive 2001/83/EC. There it says in Article 41: and in Article 46f: As the general system guarantor of a manufacturer of medicinal
products, the qualified person has to fulfil the task of implementing
these requirements. |
Other meetings of interest:
Get the latest update on this development as well as on other API related topics from FDA, EMEA and EDQM Speakers at Europe´s most important annual API Compliance Event: 9th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients in Prague www.api-conference.org |
Author: |