<p>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'.</p>
<p>ISO 18362:2016 is not applicable to:</p>
<p>- procurement and transport of cell-based starting material used in processing of a CBHP,</p>
<p>- cell banking,</p>
<p>- control of genetic material,</p>
<p>- control of non-microbial product contamination,</p>
<p>- <i>in vitro</i> diagnostics (IVDs), or</p>
<p>- natural medicines.</p>
<p>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.</p>
<p>ISO 18362:2016 does not define biosafety containment requirements.</p>
<p>ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.</p>
Registration number (WIID)
62244
Scope
<p>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'.</p>
<p>ISO 18362:2016 is not applicable to:</p>
<p>- procurement and transport of cell-based starting material used in processing of a CBHP,</p>
<p>- cell banking,</p>
<p>- control of genetic material,</p>
<p>- control of non-microbial product contamination,</p>
<p>- <i>in vitro</i> diagnostics (IVDs), or</p>
<p>- natural medicines.</p>
<p>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.</p>
<p>ISO 18362:2016 does not define biosafety containment requirements.</p>
<p>ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.</p>
