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BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing >
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BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing, 2023
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 5 Process definition [Go to Page]
- 6 Manufacturing environment [Go to Page]
- 7 Equipment [Go to Page]
- 8 Personnel [Go to Page]
- 9 Manufacture of product [Go to Page]
- 10 Process simulation and process confirmation [Go to Page]
- 11 Finished product release: test for sterility [Go to Page]
- 12 Finished product release: testing for biological contamination that cannot be detected by the test for sterility [Go to Page]
- 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 [Go to Page]
