master batch record

... workshops for detailed representation in MES, Identification of MES master data with specialist departments and implementation into the MES system, Qualified MBR design in close coordination with the specialist department;...

... purpose, quality statuses, analysis methods, and target ranges for various quality levels (also hierarchically) can be freely defined in the system. This allows synko Quality to be configured so that, for example, a master data record for an item can only be used once all necessary inputs have been completed. For quality control, measured actual qualities are stored in real-time in your IT system...

...based on QP approved Master Batch Record - QC and Release by Qualified Person (QP) - Full Quality Control complying with the European pharmacopea 5.14 will be performed: - Content and purity by UV measurement (260/280 nm) - Visual inspection - Identity by restriction and DNA sequencing (full plasmid sequencing) - Safety tests: Endotoxins, Bioburden/Sterility and Mycoplasma - Residual...