The ICH Q11 Guideline on Development and Manufacture of Drug Substances ( Chemical Entities and Biotechnological/Biological Entities). Step 3. Transmission to CHMP. May Adoption by CHMP for release for ICH guideline Q11 on development and manufacture of drug substances . endorsed by the ICH Assembly at Step 4 of the ICH process, August Do the ICH Q11 general principles for selection of starting materials apply to the.
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In order to establish a common understanding in regards to q11 information on starting materials in module 3 section 3. It remains to be seen whether this will speed up approval processes.
If a persisting impurity appears at some point during a synthetic route, it may icn acceptable to control this impurity through the specification of the starting material, even if the impurity profile of the active substance is changed. Yes, the terms are synonymous. In cases such as this, a detailed description of all synthesis steps in which these impurities are formed may be forgone in the dossier section 3. The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process.
This is covered by ICH Q The icch goes for intermediates that do not count as “commercially available” according to ICH Q Residual risks in regards to the drug substance quality are to be assessed.
The term “custom synthesised” is not defined in ICH Q11; it is generally understood to be a substance which has been synthesised specifically for pharmaceutical manufacture and in consideration of a customers’ requirements. Assessors at regulatory agencies of the Ivh member states have to evaluate whether the data provided sufficiently justify the selection.
Together with the recently published updated EMA reflection paper on API starting materialsthe applicants as well as the assessors are now provided with q1 detailed documents, which lay the foundations cih a more harmonised interpretation of ICH Q In total, the document contains 16 questions and their corresponding answers, all of which refer specifically to the guideline ICH Q11, chapter 5 ” Selection of Starting Materials and Source Materials “.
When related substances are at a level that exceeds those limits, an impact on the impurity profile is to be expected.
The criteria for this are outlined in the ICH Q11 guideline – however, not in a sufficiently precise manner. According to ICH Q11, a “commercially ih substance” is one that is offered and sold as a commodity in the non-pharmaceutical market in addition to its use as a starting material.
Changes in earlier synthesis steps upstream must be made in accordance with the quality assurance system uch the applicant. This resulted in questions and additional demands by the agencies, thereby delaying the approval processes.
In that case, the dossier has to describe a control strategy and justify the choice of starting material. The distinction between these two terms plays an important role in ICH Q11 insofar as that an applicant does not have to justify the use of ichh “commercially available” substance as a starting material in the dossier – on the contrary to “custom synthesised” compounds; those are subject to the regulations of ICH Q This means impurities which are not purged over multiple synthesis steps and possibly remain in the final product e.