BS 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'.

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 fatty acids.

This International Standard does not define biosafety containment requirements.

This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.


Cross References:
ISO 11135
ISO 11137
ISO 13022:2012
ISO 13408-1:2008
ISO 13408-1:2008/Amd.1:2013
ISO 13408-7:2012
ISO 14160
ISO 14644-4
ISO 14937
ISO 14971
ISO 17665-1
ISO 20857
ISO 22442
ISO 25424
ICH Q7
ICH Q9
ISO 9004
ISO/TS 11139
ISO 11737-1
ISO 13408-2
ISO 13485:2003
ISO 14161:2009
ISO/TR 14969
ISO/TS 17665-2
ISO 29463-1
2003/94/EC
2001/83/EC
FDA 21 CFR Part 1271
2009/41/EC
ICH Q5A(R1)
ICH Q8
AAMI TIR 37


All current amendments available at time of purchase are included with the purchase of this document.