Strategies to Simplify the Evaluation of Pharmaceutical Excipients

Register free: ​ https://www.pharmtech.com/pt_w/excipients

Event Overview:

Excipient manufacturing and process development for its use in drug production must meet GMP compliance. The suitability of pharmaceutical excipients for their intended use is defined by critical quality attributes (CQAs) such as identity, strength, and purity, which can pose numerous analytical challenges due to the complex nature of excipients.

The United States Pharmacopeia–National Formulary (USP–NF) provides continued guidance on how to specify excipient composition, including control of impurities. Further efforts from the International Council for Harmonization (ICH) are needed to set guidelines relating to the control of impurities in excipients. In this webinar, we will cover:

• Challenges associated with the control of impurities in excipients
• Analytical techniques used for the characterization of pharmaceutical excipients
• Software technology driving 21 CFR Part 11.

Key Learning Objectives:

• Use of analytical technologies to drive the control of impurities in excipients
• Understand the regulatory framework for excipients testing, with a viewpoint on the USP stimuli article, titled The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities.
• Detect possible genotoxic impurities in excipients
• Achieve data integrity by using software compliant to cGMP and 21 CFR Part 11 for FDA-regulated industries.

Time and Date: Wednesday, April 28, 2021, 8AM PDT | 11AM EDT | 4PM BST | 5PM CEST

On demand available after final airing until April 28, 2022

Sponsor: PerkinElmer

Register free: https://www.pharmtech.com/pt_w/excipients