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


Industry, Regulators Divided Over Q11 Definition of API Starting Materials

This article was originally published in The Gold Sheet

You may also be interested in...

ICH Q11 Accord Brings QbD to APIs, Defines API Starting Materials

After five years, working group members of the International Conference on Harmonization have adopted its Q11 guideline on drug substance development and manufacture, which advances QbD principles for drug substance development, especially for biotechnology products, endorses the use of prior knowledge, and establishes a harmonized definition for starting materials. Even though not everyone is happy with this definition, ICH members say that a harmonized definition is better than a non-harmonized one.

In Brief

It’s time to comment on ICH Q11

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.


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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