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ATMPs are complex products and risks may differ according to the type of product and level of complexity of the manufacturing process. The risk-based approach facilitates the manufacturer to design the organizational and technical measures that are put in place to comply with GMPs and thus to ensure quality according to the specific risks of the product and the manufacturing process. While the risk-based approach brings flexibility, it also implies that the manufacturer is responsible to put in place the control measures that are necessary to address the specific risks of the product and of the manufacturing process, and to demonstrate the aseptic capability of such processes.
Speaker(s):
Ms. Mei Kuen
Ong,
Senior Director, Global Quality & Compliance Operations,
WuXi Advanced Therapies
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