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What is IMP Packaging and Labelling SOP about?

This standard operating procedure describes the packaging and labeling of investigational medicinal products (IMPs) for clinical trials. It outlines responsibilities for printing labels, checking labels against randomization lists, packing doses according to protocols while maintaining blinding as needed, and documenting and storing packed IMPs. The SOP aims to facilitate high quality IMP management in compliance with good clinical, manufacturing, and pharmacy practices.

Author

alex

Language

EN