Subscribe to Newsletter
Manufacture Ingredients, Standards & Regulation, Small Molecules

Don’t Forget the Excipients

The International Pharmaceutical Excipients Council Federation (IPEC) has published a position paper urging pharma stakeholders to create strategies that ensure the quality of critical data for excipients. Though data integrity is an essential part of any GMP application, much of the regulatory guidance currently available does not outline data integrity requirements for inactive drug products.

IPEC suggested several ways excipient suppliers could improve their data integrity, including the ensured maintenance of product life cycles and the use of training and internal auditing to guarantee compliance with documented data integrity controls. Excipient users were also advised to “manage expectations appropriately when auditing excipient suppliers” as their data integrity controls may differ depending on the type of products developed.

The paper is available at

Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

About the Author
Maryam Mahdi

Deputy Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine