BS ISO 18362:2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of product
10 Process simulation and process confirmation
11 Finished product release: test for sterility
12 Finished product release: testing for biological
   contamination that cannot be detected by the test for sterilit
Annex A (informative) - Examples of microbial risks for CBHP
Annex B (normative) - Decision trees for application of risk
        assessment for cell-based starting materials
Annex C (informative) - Containment facilities
Annex D (normative) - CBHP starting material
Annex E (normative) - Containment requirements for procured,
        non-sterile starting materials before entering the
        manufacturing area
Annex F (informative) - Typical elements of a process definition
Bibliography

Defines the minimum requirements for, and gives 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.

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:

• 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.

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.