The IPEC Validation Guide for Pharmaceutical Excipients was issued in January 2021. The guide was developed to help describe activities taken by excipient manufacturers to test and evaluate their systems, processes and methods in order to provide a high degree of assurance that they consistently produce results, meeting predetermined acceptance criteria. It recognizes that an excipient manufacturer performs “validation” activities differently than API and drug manufacturers.
Although current excipient Good Manufacturing Practices (GMP) standards and guides do not require validation, they do require demonstration of consistent operation of the excipient manufacturing process based on knowledge of process parameters, product attributes and their inter-relationship. This implies the need for validation type activities to demonstrate a state of control. The validation guide includes best practices for how to document these activities in a manner that meets the excipient user’s expectations.
This webinar will highlight key elements of validation activities from initiation through reporting and continuous monitoring. Examples of how excipient manufacturers might apply some of the concepts will be provided.
Learning / Awareness Objectives
During this webinar, participants will learn how validation of excipients is different from APIs and finished drugs, and be able to identify validation considerations and documentation necessary to meet excipient user and GMP standard expectations.
In addition, the webinar will cover
> Understanding of excipient validation
> The IPEC Validation Guide and its approach
> Validation activities implied in excipient GMP standards/schemes
> Considerations for excipient validation