Qualified Person Must Confirm API-Related Notification of Changes

GMP News No. 760

GMP News
14 July 2006

Qualified Person Must Confirm
API-Related Notification of Changes

In June, the EC Commission published the revised  "Guideline on dossier requirements for type IA and IB notifications".

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:

  • The replacement of a manufacturing site for the complete manufacturing process or a part of it
  • Changes in the locality of quality control and batch release
  • Choosing a different API manufacturer or a different supplier of starting materials, reagents, intermediates within the framework of API manufacture if no CEP (Certificate of Suitability) is available
  • When a new or updated CEP for an API, starting material, reagent or intermediate is handed in

These additional requirements in the revised guideline consistently bridge the gap to Directive 2001/83/EC. There it says in 

Article 41:
"In order to obtain the manufacturing authorization, the applicant shall [...] specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled; [...]"

and in Article 46f:
[...] "to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials."

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


The revised "Guideline on dossier requirements for type IA and IB notifications" can be found here.

Dr Gerhard Becker
On behalf of ECA

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