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 anticipates Q&As will lead to smoother implementation

This article was originally published in The Gold Sheet

Executive Summary

The ICH Quality Implementation Working Group has developed a question-and-answer guide to help manufacturers implement its Q8, Q9 and Q10 guidelines. The Q&A has three QbD topics: design space, real-time release testing, and control strategy. ICH announced that "the benefits of harmonizing technical requirements across the ICH regions can only be reached if the various Q-ICH guidelines are implemented and interpreted in a consistent way across the three regions." The document was approved by the ICH Steering Committee as a Step 4 document on April 14

You may also be interested in...

ICH Adds More Q&As

The ICH Quality Implementation Group in October added several questions and answers to its guide for helping manufacturers implement its Q8, Q9 and Q10 guidelines. One of the additional questions is: "What is an appropriate approach for process validation using ICH Q8, Q9 and Q10?" The answer: "the objectives of process validation are unchanged when using ICH Q8, Q9 and Q10. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria…As an alternative to the traditional process validation, continuous process verification can be utilized in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle." ICH also addressed the role of risk management and continuous process verification in continuous improvement, clarified that parametric release is a type of real-time release, and explained that under QbD, even with real-time release testing, the product would still have to meet traditional specifications if subjected to end product testing. The agency also clarified that under Q10, some elements of the control strategy are subject to inspection

Sickle Cell Gene Therapy May Need New US-Backed Payment Program, Grogan Suggests

Former senior advisor to President Trump warns that failure to reform drug pricing practices has seriously handicapped prospects for reimbursing cell and gene therapy under existing US payer programs.

Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.




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