ISO 18362:2016/Amd 1:2022 PDF
Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 2
- Дата публикации:
- 21 июня 2022 г.
- Издание:
- ISO IS 18362 edition 1 version 1
- ICS:
- 11.080.01
Abstract
Overview
ISO 18362:2016/Amd 1:2022 is an important amendment to the international standard addressing the manufacture of cell-based health care products with a focus on the control of microbial risks during processing. Developed by ISO Technical Committee ISO/TC 198, which specializes in sterilization of health care products, this amendment updates key processes and requirements essential to ensure the safety and quality of advanced cellular therapies and related health care products.
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