Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement
5 Selection of product
5.1 General
5.2 Sample item portion (SIP)
5.3 Packaging of product and Sample Item Portions
6 Methods for performing tests of sterility
7 Assessment of method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) Guidance on tests of sterility performed
in validation of a sterilization process
A.1 Scope
A.2 Normative references
A.3 Definitions
A.4 Quality management system elements
A.4.1 Documentation
A.4.2 Management responsibility
A.4.3 Product realization
A.4.4 Measurement, analysis and improvement
A.5 Selection of product
A.5.1 General
A.5.2 Sample Item Portion (SIP)
A.5.3 Packaging of product and Sample Item Portions
A.6 Methods for performing tests of sterility
A.7 Assessment of method for performing tests of sterility
A.8 Maintenance of the method for performing tests of
sterility
Bibliography