Foreword
0 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 sterility
Annex A (informative) - Examples of specific risks for CBHP
Annex B (normative) - Decision trees for application of risk
assessment for 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