Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/198
Supersedes	14/30266295 DC : 0