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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This resulted in questions and additional demands by the agencies, thereby delaying the approval processes. 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.

ICH Q11 reaches Step 4 of the ICH Process

Yes, the terms are synonymous. Residual risks in regards to the drug substance quality are to be assessed. 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 “.

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ICH Q11 Q&A reaches Step 4

Cookies help us in providing our services. Together with the recently published updated EMA reflection paper on API starting materialsthe applicants as well as the assessors are now provided with sufficiently detailed documents, which lay the foundations for a more harmonised interpretation of ICH Q In that case, the dossier has to describe a control strategy and justify the choice of starting material.


The selection of cih starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. The same goes for intermediates that do not count as “commercially available” according to ICH Q In order to establish a common understanding in regards to the information on starting materials in module 3 section 3.

These concepts should logically be applied to steps upstream of the starting material as well. When related substances are at a level that exceeds those limits, an strp on the impurity profile is to be expected.

The ICH Q11 Q&A reaches Step 4 of the ICH Process : ICH

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 a “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 However, the regulations in ICH Q7 relate to the GMP compliant manufacture wtep active substances, not the procedure of selecting and justifying starting materials.

It remains to be seen whether this will speed up approval processes. The criteria for this are outlined in the ICH Q11 guideline – however, not in a sufficiently precise manner.


ICH Q11, section 9 describes basic scientific and risk-based concepts for the evaluation of post-approval changes to the starting material. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. 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 starting material, even if the impurity profile of the active substance is changed.

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.

Changes in earlier synthesis steps upstream must be made setp accordance with the quality assurance system of the applicant. This means impurities which are not purged over multiple synthesis steps and possibly remain in the final product e. 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.

This is covered by ICH Q