This user friendly tool is intended to assist companies with logistical and shipment questions/issues for ATMP shipment. ATMPs are significantly more fragile and valuable than most small molecule and biological medicines. Therefore, quality systems, validation, and traceability are mandated to mitigate risk and ensure safe delivery of cell and gene therapies in a zero-failure environment.
Ensuring safe delivery of cell and gene therapies!
Read up on ”What is GDP”, what companies need to do, what regulators expect and FAQ answered by regulators. From planning and ready to ship, this resource will assist you in building the correct procedure.
Figure 1: Planning and ready to ship procedure (by John Coleman, YSDS Life Science)