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.

Author: Doulkree Kigakazahn
Country: Yemen
Language: English (Spanish)
Genre: Career
Published (Last): 14 June 2013
Pages: 192
PDF File Size: 5.65 Mb
ePub File Size: 16.16 Mb
ISBN: 252-6-37917-780-3
Downloads: 12583
Price: Free* [*Free Regsitration Required]
Uploader: Mitaur

ICH Q11 Q&A reaches Step 4

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” icy as a starting material in the dossier – on the contrary to “custom synthesised” compounds; those are subject to the regulations of ICH Q The same goes for intermediates that do not xtep as “commercially available” according to ICH Q 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 However, the regulations in ICH Q7 relate to the GMP compliant manufacture of active substances, not the procedure of selecting and justifying starting materials.

Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently idh the selection.


Yes, the terms are synonymous. In that case, the dossier has to describe a control strategy and justify the w11 of starting material. The criteria for this are outlined in the ICH Q11 guideline – however, not in a sufficiently precise manner.

API starting materials – New Q&A document for ICH Q11 – ECA Academy

If you have problems displaying the website, is maybe JavaScript disabled on your browser, or your browser does not support JavaScript! In total, the document contains 16 questions and their corresponding answers, all of which refer specifically to the guideline ICH Ifh, chapter 5 ” Selection of Starting Materials and Source Materials “.

It remains to be seen whether this will speed up approval processes. ICH Q11, section 9 describes basic scientific and risk-based concepts for the evaluation of post-approval changes to the starting material. Cookies help us in providing our services. Changes in earlier synthesis steps upstream must be q111 in accordance with the quality assurance system of the applicant.

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

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. By using our services, you agree that we use cookies.

This resulted in questions and additional demands by the agencies, thereby delaying the approval icch. 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. This means impurities which are not purged over multiple synthesis steps and possibly remain in the final product e.


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.

When related substances are at a 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 steps in the approval process.

Icch concepts should logically be applied to steps upstream of the starting material as well.

In order to establish a common understanding in regards to the information on starting materials in module 3 section 3. In cases such as this, a stsp description of all synthesis steps in which these impurities are formed may be forgone in the dossier section 3. Residual risks in regards to the drug substance quality are to be assessed.

This is covered by ICH Q

Author: admin