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?
I will collate all comments and respond on behalf of the PQG members by the deadline for the consultation. With this in mind, can you provide all comments by the 20th April 2012
Thanks!
2 Responses to “GMP for APIs”
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The directive 2003/94 as written only applies to Human medicines and only replaces 91/356 for Human health. The Animal health directives for pharmaceuticals is stil 91/356 and therefore the falisfied medicine directive 2011/62 only applies to Human pharmaceuticals.
The GMPs for solely Animal healthAPI is therefore not the same and will continue to widen in requirements. Is anything going to change this effect?
This suonds like an interesting topic. API’s have a lot of potential for leveraging shared data sources, for defining a shared base of content and services that scholars can then repurpose and extend (possibly with some technical help, possibly by learning to do it on their own) to present their own analysis and interpretation without having to create the entire project from scratch. Perhaps we could spend some time talking about the design principles for creating RESTful APIs as well as the some of the benefits/drawbacks to these approaches (e.g., what are the sustainability implications if I create a project that depends on someone else’s API). For the hack-a-thon, it might be useful to have one or two project domains in mind. I’d be interested in walking through a general purpose API for representing digital facsimiles. I think that might be something that is broad enough that we can get both technical and non-technical people working on and yet (hopefully) have something cobbled together in an hour or so. I’m sure that there are other interesting projects out there as well. Are there other types of resources that people would be interested in hacking up?