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 the information on starting materials in module 3 section 3. Together with the recently published updated EMA reflection paper on API starting materialsthe applicants stpe well as the assessors are now provided with sufficiently detailed documents, which lay the foundations for a more harmonised interpretation of ICH Q 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.
This resulted in questions and additional demands by the agencies, thereby delaying the approval processes. 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 “.
Cookies help us in providing our services. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection.
This is covered by ICH Q Residual risks in regards to the drug substance quality are to be assessed.
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. Changes in earlier synthesis steps upstream must be made in accordance with the quality assurance system of the applicant. When related substances are at ztep level that exceeds those limits, an impact on the impurity profile is to be expected.
The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial ic in the approval process.
ICH Q11, section 9 describes basic scientific and risk-based concepts for the evaluation of post-approval changes to the starting material. If a persisting impurity appears at some point during a synthetic route, it may be acceptable to control this impurity through the specification of the stsp material, even if the impurity profile of the active substance is changed.
According to ICH Q11, a “commercially available 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.
However, the regulations in ICH Q7 relate to the GMP compliant manufacture of active substances, not the procedure of selecting and justifying starting materials. Yes, the terms are synonymous.
It remains to be seen whether this will speed up approval processes. The same goes for intermediates that do not count as “commercially available” according to ICH Q In that uch, the dossier has to ixh a control strategy and justify the choice of starting material.