1 Scope
This International Standard 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'.
This International Standard 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 fatt...
BS ISO 18362:2016+A1:2022 history
2023BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing
2016BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing