Norme internationale
Manufacture of cell-based health care products — Control of microbial risks during processing
Publié 15 janv. 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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.
Publiée · 21 juin 2022