On Tuesday 22 September 2020 PQG organised a Data Integrity Webinar with Dale Carter, Head of Quality – Evonik Corporation.
In this presentation, Dale reviewed the recently released position paper on Data Integrity for Pharmaceutical Grade Excipients published by the International Pharmaceutical Excipients Council Federation (IPEC).
The paper was developed to supplement published Regulatory guidance defining Data Integrity requirements for drug substances and medicinal products, some of which are not easily adaptable to the manufacture of excipients.
The presentation (supporting slides available here) covered Data Integrity principles, Regulatory guidance documents and recommendations on how to apply Data Integrity to excipient manufacturing and distribution.