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

Executive Summary

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

You may also be interested in...



Pharmaceutical Manufacturers Grapple With ICH Q3D Implementation

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.

Excipient Database Should Help Take Mystery Out Of ICH Q3D Risk Assessments

The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.

FDA Urges Firms To Control Metal Impurities From Equipment And Containers

Drug makers working to comply with new ICH Q3D metal impurity standards should pay special attention to the possibility of metals leaching from manufacturing equipment and container closures, an FDA official says at agency workshop.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132356

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