Alcance
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.