GMP for APIs

Introduction

Directive 2003/94/EC is well known and is often referred to colloquially as the ‘GMP directive’. ¬†With the recent directive (2011/62/EU) signifying increasing focus on falsified medicines and therefore more control on starting materials, excipients and APIs, the need to extend the scope of 2003/94/EC to include APIs is required.

The delegated act to amend the scope of 2003/94/EC to include APIs and hence facilitate the amending directive 2011/62/EU on 2001/83/EC is now open for public consultation

Some points of interest:

  • The API manufacturer is required to ensure the starting materials used in the API they manufacture are indeed from the site stated.
  • Confirmation of exceptions from the scope and specific definitions for inclusion.

To open the consultation on the proposed delegated act, please click HERE

How do you comment?

Simply add comments in the comment field of this page or email me on advocacy@pqg.org

Please make it clear which part of the text you are referring to (i.e. chapter heading) and provide as much information as possible to add maximum value.

In the case of this delegated act the specific areas for comment are highlighted in the document.

When should you comment by?

This consultation is now closed

Thanks!