Reference number
ISO 18362:2016
International Standard
ISO 18362:2016
Manufacture of cell-based health care products — Control of microbial risks during processing
Edition 1
2016-02
Read sample
ISO 18362:2016
62244
Published (Edition 1, 2016)
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.
This standard has 1 amendment.

ISO 18362:2016

ISO 18362:2016
62244
Language
Format
CHF 151
Convert Swiss francs (CHF) to your currency

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.

General information

  •  : Published
     : 2016-02
    : International Standard confirmed [90.93]
  •  : 1
     : 32
  • ISO/TC 198
    11.080.01 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2022

ISO 18362:2016/Amd 1:2022
81822
Language
Format
CHF 18
Convert Swiss francs (CHF) to your currency

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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