Active standard | Published: 15/01/2016

ISO 18362:2016

Manufacture of cell-based health care products — Control of microbial risks during processing
(Manufacture de produits de soins de santé fondés sur les cellules — Contrôle des risques microbiaux durant le processus)

Available languages: English

Available design: electronic design (pdf), Print design

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Detail information

Designation: ISO 18362:2016

Publication date: 15/01/2016

Pages: 32

Country: International technical standard

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Anotation

Description / 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.

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