Roche Diagnostics GmbH - Qualification and Validation of the whole site successfully completed
In the field of diagnostics, the world leading Swizz company Roche has built a new site in Graz. The complex has a useable area of around 8,200 m2, employs around 370 people and incooperates different departments for production, reseach, development and administartion. The product portfolio of the Graz site encompasses enquipment, sensors, and chemicals for the in-vitro testing of blood gases, electrolytes, intermediate catabolic metabolic product and haemoglobin derivatives.
In addtion, state-of-the-art IT solutions for networking and data management of patient-data in the different departments of a hospital are offered within the product spectrum.
For the chemical production, the sensor production and equipment production, the Graz site offers separate, classified production areas.
In the course of the new development apparatus had to be transfered from other locations and all GMP-revelant rooms, apparatus and computer systems had to be qualified and validated.
VTU-Engineering lead the basic engineering of the chemical production facility and was later asked to plan and execute the qualification.
The Qualification project NEW SITE GRAZ was successfully completed by VTU at the beginning of 2004.
As a result of the good co-operation and high costumer satisfaction VTU was further contracted out to do the cleaning validation and plan and execute the process validation.
Within the scope of the qualification-projects VTU, in cooperation with the respectively responsible internal department of Roche, conducted the following activities:
- Compilation of guidelines and operating procedure to qualify and validate automated systems
- Compilation of plant specific and oraganisatioal operation procedures
- Qualification master planning
- (Impact Assessment and qualification master plan and report)
- Compilation of qualification plans and reports
- Qualification of the individual process units of an manufacturing unit for chemical agents
- Qualification of ulitity systems (purified water, CIP, RLT, gas supply, ...)
- Qulification of clean rooms
- Support in auditing suppliers
- Supporting suppliers regarding checks and documentation accoring to GMP rules