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


EU Considers Including High-Profile Excipients in Applying GMP to API

This article was originally published in The Gold Sheet

Executive Summary

Political pressure in the EU puts two in-the-news excipients on EU GMP list.

You may also be interested in...

Industry is Developing a More Profound Understanding of Excipients

Deeper understanding of the role of excipients in drug formulations is leading manufacturers and pharmacopoeias to develop new more science-based approaches and standards for them. Variability of excipients should be expected: the key is to know which variables are important - and how to counterbalance them. The flexibility of QbD could play a key role. Compendial tests often do not focus on the critical attributes. USP and EP are working to upgrade their excipient standards. USP <1059> draft is seen as step in the right direction with its offering of functional guidance in a general information chapter. Industry fears the 'non-mandatory' functionality-related tests the EP wants to add to excipient monographs would eventually become mandatory. FDA and IPEC work to unfetter novel excipients. FDA would create an excipient functionality database. Regulatory requirements for excipients could be helpful, but progress is slow. Third-party certification could suffice in the interim, though uptake remains slow.

The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

Latest Headlines
See All



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