ISO 18362:2016

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Manufacture of cell-based health care products — Control of microbial risks during processing

Published By	Publication Date	Number of Pages
ISO	2016-02	42

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Categories: 11.080.01 - Sterilization and disinfection in general, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2016-02
Pages Count	42
Language	English
Edition	1
File Size	778.2 KB
ICS Codes	11.080.01 - Sterilization and disinfection in general

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ISO 18362:2016

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