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A GMP-compliant QMS is more than inspections of facilities, devices, processes and materials

Of central importance in a GMP-compliant product transfer is validation of the manufacturing process, validation of analytical methods, and qualification of all relevant process facilities.

Our experts support you with defining the manufacturing process, determining suitable research-based specifications, production of technical batches, and successful production of validation batches. For this purpose there are a variety of approaches that can be taken as needed for process validation, for example “bracketing,” which can greatly reduce validation work and remain compliant with applicable guidelines.

Bastian Kloefer – Manager, Product Transfers & Business Development Support

Bastian Kloefer

Manager, Product Transfers & Business Development Support

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