1 Scope
This International Standard 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:
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— procurement and transport of cell-based starting material used in processing of a CBHP,
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— cell banking,
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— control of genetic material,
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— control of non-microbial product contamination,
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— in vitro diagnostics (IVDs), or
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— 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.