Outsourcing Facility Compounding - Webinar Recording/Transcript
Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities
In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.
How will these new requirements affect you?
Lee H. Rosebush — partner at Baker Hostetler and chairman of the Outsourcing Facilities Association — will address the newly proposed standards and will discuss several outstanding questions the industry must confront. After 90-minutes of discussion you’ll understand how to:
- Comply with the nuances of the revised guidance — including the new line drawn between sterile and non-sterile drug products
- Implement best practices to protect against contamination
- Comply with the guidance while making it feasible for outsourcing facilities to fulfill requests for office stock and maintain product quality
- Ensure that a compounder’s quality control conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products
- Conduct annual quality standard evaluations of drug products
- Comply with FDA evaluation requirements
- Comply with revisions on release testing, reserve samples, the definition of “in-use time”, the use of third party laboratories for testing purposes and stability testing
- Understand issues left unresolved by the guidance
This presentation will help you understand the new requirements presented by the revised guidance and how to comply with them.