In a very tight schedule, all necessary documents were created as part of the SAT and all necessary functions, software and alarm tests of the entire filling system were carried out and documented in accordance with GMP. Additions to missing tests and adjustments to the documentation followed too.
Due to the very satisfactory advisory support and the hands-on mentality, rantronik was commissioned with the subsequent qualification of the filling system and the validation of the processes after completion of the SAT.
Risk analyses for the individual modules of the filling system and a traceability matrix were created and used as the basis for the development of all necessary test plans (IQ / OQ / PQ).
After successfully completing the “Installation Qualification” (IQ) and the “Operational Qualification” (OQ), the “Performance Qualification” (PQ) was carried out and documented under production conditions.
If deviations occurred due to the very tight schedule from conceptual design to delivery of the system, deviation plans with corresponding measures were drawn up and the coordination and documentation of the processing of the measures was assumed.
Subsequently, rantronik provided support in the validation of the processes on the nasal spray filling system.
We would be happy to support you fully with all our expertise in project phases such as FAT, SAT, qualification and validation.
Please feel free to contact us.