Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


ICH Proposes Harmonization of Drug Substance Manufacturing Processes

This article was originally published in The Gold Sheet

Executive Summary

On April 11, 2008, ICH proposed in a Q11 concept paper that the manufacturing process for drug substances be harmonized. ICH notes that "because of a lack of guidance in the area of drug substance development and manufacturing manufacturers, no general developed harmonized approaches to demonstrating process understanding, particularly regarding sources of variability in product quality, are currently available. Additionally, region-specific requirements are conveyed to the applicants by the authorities on a case-by-case basis. In general, there is currently little consensus or agreement across the industry and the regulatory bodies with respect to manufacturing process information and justification that should be included in the dossier." During discussions at the ICH-Q Drug Substance Roundtable meeting held in Washington in September 2007, participants agreed that many of the principles and concepts that have been addressed in ICH guidelines Q8, Q9 and Q10 are also applicable to the development and manufacture of drug substances. Some examples of technical elements that were recognized as having a "strong need for harmonization" include the selection of materials and components for drug substance manufacture; identification and justification of key manufacturing steps; process controls; process parameters; choice of analytical procedures and acceptance criteria as elements of a total control strategy designed to ensure product quality and consistency; the capacity of processes to reduce or remove impurities and product-related substances; and the evaluation of process robustness. The first meeting of the expert working group is expected to be held later this month. The document is currently in Step 1, which is the consensus-building stage. It is anticipated that the paper will be approved as a Step 2 document in the fourth quarter of 2009 and will receive a step 4 signoff in the fourth quarter of 2010

You may also be interested in...

ICH Q11 Aims to Harmonize Principles for Drug Substance Development and Choice of Starting Materials

A guideline the International Conference on Harmonization will soon release on drug substance quality attempts to better define regulators’ expectations for drug substance development and to better harmonize these expectations among the ICH regions within the quality by design framework.

Biocon Biologics Refreshes Management

Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.

Optibac Launches Natural Children’s Probiotic Immunity Supplement In Sustainable Pack

The UK's Optibac responds to sustainability and naturals trends with an all-in-one immunity and gut health food supplement especially designed for children.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts