Personnel Issues Addressed in Concept Paper

1. Personnel Issues Addressed in Concept Paper Robert Sausville Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Advisory Committee for Pharmaceutical Science October 22, 2002 Sterile Drug Products Produced by Aseptic Processing

2. Personnel • Personnel pose a substantial risk to the aseptic environment • Organisms contributed directly by the individual • Organisms using the individual for transportation to the critical environment

3. Personnel • poor aseptic technique combined with • poor gowning technique at these critical control points • Results in reduced sterility assurance.

4. Personnel; Risk Reduction Techniques • Restrictions on personnel to critical areas • Appropriate Gowning • Good sanitization procedures • Environmental monitoring of personnel • Sound Training Program • Clean room operating procedures • Gowning procedures • Aseptic technique • Appropriately qualified • Successful gowning qualification • Successful media fill simulation

5. Personnel Aseptic Techniques • Organisms can be introduced into aseptic products and components by • Direct contact with non sterile surfaces (gloves) • Entrainment of organisms in the laminar flow air from the compromised personnel • Contact sterile material with sterile instruments • Do not disturb the laminar air flow with • Rapid movements • Talking • Obstructions • Move slowly and deliberately

6. Personnel Expectations Monitoring Program • Monitoring of personnel is used to • Qualify/requalify individuals for aseptic processing operations to reduce risk to the products being filled • Provide a snap shot in time of the conditions the product is exposed to during aseptic filling operations • Provide an early warning of potential problems if excursions are discovered