ISO 18362:2016

Manufacture of cell-based health care products — Control of microbial risks during processing

Publication date:   Jan 15, 2016

General information

90.93 Standard confirmed   Oct 20, 2021

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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Scope

ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'.
ISO 18362:2016 is not applicable to:
- procurement and transport of cell-based starting material used in processing of a CBHP,
- cell banking,
- control of genetic material,
- control of non-microbial product contamination,
- in vitro diagnostics (IVDs), or
- natural medicines.
EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.
ISO 18362:2016 does not define biosafety containment requirements.
ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

Life cycle

NOW

PUBLISHED
ISO 18362:2016
90.93 Standard confirmed
Oct 20, 2021

CORRIGENDA / AMENDMENTS

Amended by
ISO 18362:2016/CD Amd 1

Amended by
ISO 18362:2016/Amd 1:2022