|
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.
|
