Case story
New Final Handling qualification of process and supply plant
Qualification (URS, IQ, OQ and PQ) of a process and supply plant at a new facility at Syntese A/S for API final handling. The facility includes a centrifuge, a vacuum dryer and a powder management plant including a supply facility (GMP and non-GMP).
The process
Process Engineering was responsible for project management in the creation of URS, IQ, OQ and PQ protocols, test and IQ and OQ reports. We had two weekly whiteboard meetings to follow up on status and progress in the projects. In order to streamline the process we focused on using commissioning material such as raw data in the qualification. All of this took place in partnership with Syntese A/S.
The process plants included a centrifuge, a vacuum dryer and powder management, and the supply plants included alcohol, process water, air pressure and nitrogen.
Service and scope of the project
- Project management
- Whiteboard meetings
- Preparation of URS
- Preparation of IQ, protocol, test and report
- Preparation of OQ, protocol, test and report
- Preparation of PQ protocol
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