ISO 18362:2016

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.