Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

ICH Q9 Revision Published For Public Comment

Executive Summary

ICH Q9 draft published for public consultation; changes focus on addressing subjectivity in quality risk management and managing risk for supply chains, among other topics.

You may also be interested in...



US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages

Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.

Regulators Led Bid To Strengthen ICH Q9 Quality Risk Management

Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS145419

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

Cancel