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

GMP News No. 121

GMP News
25 July 2001

ICHGuideline Published as Annex to the EU Guide to Good ManufacturingPractice, Eudralex Volume 4


The following News was published on the websiteof the European Commission. "On 18th July 2001, the Commissionadopted a new legislative proposal which introduces a requirement forpharmaceutical manufacturers to use only active substances which have beenmanufactured according to GMP in the manufacture of medicinal products.Until this comes into force requirements for GMP for active substances andhence the applicability of this guideline will not be mandatory in the EU.However when there are causes for concern, or when required by certainMember States, GMP inspections of active ingredient manufacturers may becarried out by the competent authorities of Member States. In these cases,and in particular when these are performed in the context of anapplication for a centralised authorisation, it has been agreed that theinspectors of the competent authorities in the EU will inspect against therequirements in this guideline, now published as Annex 18 to the EU guideto Good Manufacturing Practice." 
Click here to downloadthe new Annex 18



The ICH Q7a was finalised and adopted(Step 4 of the ICH process) in November 2000 at the ICH 5 meeting in SanDiego. Recently, on 18th July 2001, the European Commission hasadopted a new legislative proposal '(…) which introduces arequirement for pharmaceutical manufacturers to use only active substanceswhich have been manufactured according to GMP inthe manufacture of medicinal products (…)' (see 'Proposal for aAnnex 18 to the EU Guide to Good Manufacturing Practice'). Until the guideis implemented Annex 18 ('Good Manufacturing Practice for ActivePharmaceutical Ingredients) has no legal force at all and will not bemandatory in the EU. Nevertheless, the EU proposal makes clear that incases of causes for concern, or when required by a certain Member State,'(…) it has been agreed that the inspectors (…) will inspectagainst the requirements in this guideline (…)".

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

The ICH Q7a guide applies to APIs for usein human drug (medicinal) products that are produced by chemicalsynthesis, by extraction, by cell culture/fermentation and by recoveryfrom 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 requirementsto be applied).

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

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

Though ICH Q7a gives guidance on how tocomply with GMP principles and requirements, there still remain lots ofquestions regarding the interpretation of the guide and the implementationinto the daily work.



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