BS ISO 18362:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
07-02-2023
31-01-2016
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
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