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


Pharmaceutical Manufacturers Grapple With ICH Q3D Implementation

Executive Summary

Pharmaceutical manufacturers say that complying with ICH Q3D presents a host of challenges, and that the more difficult task is conducting a risk assessment rather than actual testing for elemental impurities. Companies are finding that they should allow plenty of time for risk assessments.

You may also be interested in...

It’s Time To ‘Get Moving’ To Meet ICH Q3D Deadline, Industry Told

A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.

ICH Q3D Metal Impurities Guidance Issued By FDA, EMA, Health Canada

Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.

US FDA Launches Quality Maturity Pilots That Reward High-Performing OTC, Rx Manufacturers

One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”


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