GOOD MANUFACTURING PRACTICE

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Existing research and laboratory protocols needed to be translated into a documentation set complying with the Good Manufacturing Practice which is required for all therapeutic clinical applications. To ensure the standards required by GMP are followed, material specifications are established based on separate material-specific risk analysis. The production process is evaluated separately for any risks that may occur during every production step. Microbiological risk analyses are performed to define acceptance criteria which samples must fulfill during the production process. These microbiological analysis methods as well as any other method used during the production need to be verified for each specific sample type. Test runs are performed to assess the interplay of each individual component. Based on obtained insights during these test runs, the actual working and compounding instructions (former lab SOPs) are finalized. The full process is then validated when several pre-patient batches passed all analytical tests and no major deviations occurred during these runs. Last but not least, and repeated every half year, the process needs to be simulated with highly potent bacterial growth media to ensure the aseptic working habits of the production team members.