ICH Guideline Published as Annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4

ICH Guideline Published as Annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4

The following News was published on the website of the European Commission. "On 18th July 2001, the Commission adopted a new legislative proposal which introduces a requirement for pharmaceutical manufacturers to use only active substances which have been manufactured according to GMP in the manufacture of medicinal products. Until this comes into force requirements for GMP for active substances and hence the applicability of this guideline will not be mandatory in the EU. However when there are causes for concern, or when required by certain Member States, GMP inspections of active ingredient manufacturers may be carried out by the competent authorities of Member States. In these cases, and in particular when these are performed in the context of an application for a centralised authorisation, it has been agreed that the inspectors of the competent authorities in the EU will inspect against the requirements in this guideline, now published as Annex 18 to the EU guide to Good Manufacturing Practice." 
Click here to download the new Annex 18

If you want to get more Details about the new annex and to new FDA Trends click here to read all about the APIC/CEFIC 4th European Conference on Active Pharmaceutical Ingredients, to be held in Vienna on 26 - 28 September.
 

Details

 
The ICH Q7a was finalised and adopted (Step 4 of the ICH process) in November 2000 at the ICH 5 meeting in San Diego. Recently, on 18th July 2001, the European Commission has adopted a new legislative proposal '(…) which introduces a requirement for pharmaceutical manufacturers to use only active substances which have been manufactured according to GMP in the manufacture of medicinal products (…)' (see 'Proposal for a Annex 18 to the EU Guide to Good Manufacturing Practice'). Until the guide is implemented Annex 18 ('Good Manufacturing Practice for Active Pharmaceutical Ingredients) has no legal force at all and will not be mandatory in the EU. Nevertheless, the EU proposal makes clear that in cases of causes for concern, or when required by a certain Member State, '(…) it has been agreed that the inspectors (…) will inspect against the requirements in this guideline (…)".

Though there is still no legal force for the implementation of GMP for the manufacture of APIs, this last statement emphasises the importance of the future 'Annex 18'.

The ICH Q7a guide applies to APIs for use in human drug (medicinal) products that are produced by chemical synthesis, by extraction, by cell culture/fermentation and by recovery from natural sources as well as for any combination of these processes. (Remark: Veterinary products in general are covered by VICH guidelines. Regarding the ICH Q7a it seems reasonable to expect similar requirements to be applied).

Even 'Agents, brokers, traders, distributors, repackers, and relabellers of APIs' (section 17) are covered by this guide in order to '(…) explicate GMP standards for the entire API supply chain in light of several recent international cases involving fraud and counterfeit (…)' (see Gold Sheet, August 2000). One of these cases resulted in the death of more than 80 children in Haiti.

ICH Q7a consists of 19 sections and a glossary (section 20). Sections 1 to 16 apply to the manufacture of APIs in general, sections 17 to 19 apply to specific items like 'agents, brokers, traders, distributors, repackers, and relabellers of APIs' – as mentioned above - to APIs manufactured by cell culture/fermentation and to APIs for use in clinical trials in order to give additional guidance. These sectors should not be seen separately, but in conjunction with the rest of the guide.

Though ICH Q7a gives guidance on how to comply with GMP principles and requirements, there still remain lots of questions regarding the interpretation of the guide and the implementation into the daily work.

The latest news of GMP for APIs and guidance on interpretation of ICH Q7a will be presented at the 4th CEFIC/APIC Conference on Active Pharmaceutical Ingredients. The conference takes place in Vienna/Austria from 26 to 28 September. Representatives of international API manufacturers as well as officials both from European authorities and from the American Food and Drug Administration (FDA) are going to speak at the conference. They will address important topics such as Post-Approval Changes, GMP Compliance for Premises and Equipment, BSE/TSE in Active Pharmaceutical Ingredients and Counterfeits of Active Pharmaceutical Ingredients.

For more details, please contact us (Dr. Barbara Jentges, phone +49-6221-844413, E-mail: jentges@concept-heidelberg.de) or read the on-line programme. Furthermore already you can participate in the electronic discussion forum of this conference on the web. Please find an instruction how to surf the web for this pre-discussion mentioned below.

Use the Electronic Discussion Forum on the Web to Ask Your Questions to the Specialists Prior to the 4th CEFIC/APIC Conference

Then you can choose one of the 6 working groups for asking your questions (as shown in the picture above). 

Click "New contribution" and ask questions or comment contributions that are already in the forum.