ISO 18362:2016/Amd 1:2022 is an amendment to the ISO 18362:2016 standard, which deals with the control of microbial risks during the processing of cell-based health care products (CBHPs). The amendment, published in 2022, provides updated guidance and requirements for ensuring the safety and efficacy of these products. The standard applies to both sterile and non-sterile CBHPs.
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