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ISO 18362:2016
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Manufacture of cell-based health care products -- Control of microbial risks during processing

(Not available in French)

Abstract

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.

 

  • Document published on: 2016-02
    Edition: 1 (Monolingual) ICS: 11.080.01
    Status: Published Stage: 60.60 (2016-01-15)
    TC/SC: ISO/TC 198 Number of Pages: 32
     
  • This standard has not been revised

  • No corrigenda or amendments available

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