Objective
Provide technical and compliance support on-site during critical steps of the pre-PPQ and PPQ runs of a complex and highly innovative synthetic active pharmaceutical ingredient
Outcome
- Successful integration with the local manufacturing and QA teams while providing real-time support as well as communication to the sponsor’s expert teams
- Timely completion of the PPQ runs
- Hands-on investigations of deviations; contribution to several improvements
- Support to the cleaning validation strategy
- Preparation of several source documents supporting the validation reports