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

Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says

Executive Summary

Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.

You may also be interested in...



ICH Q9 Revision Published For Public Comment

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.

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.

Quality Risk Management Adoption More Wide Than Deep – Survey

A high percentage of pharmaceutical companies say they have the quality risk management programs in their manufacturing facilities that US and EU inspectors are asking for. But many of them are not yet very mature.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123156

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