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

UsernamePublicRestriction
UsernamePublicRestriction

ICH Adds More Q&As

This article was originally published in The Gold Sheet

Executive Summary

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

You may also be interested in...



ICH anticipates Q&As will lead to smoother implementation

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

Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors

But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.

UsernamePublicRestriction

Register

ID1131516

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

Cancel