FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Batch production record description
4.1 Introduction
4.2 Batch production record
4.3 Batch production record purpose
4.4 Batch production record data management
4.5 Batch production record structure
4.6 Production information
4.7 Batch production record elements
5 Batch production record object model
5.1 Introduction
5.2 Modelling information
5.3 Batch production record object model overview
5.4 Batch production record
5.5 Batch production record entry
5.6 Event
5.7 Data set
5.8 Comment
5.9 Sample
5.10 Change
5.11 Personnel identification manifest
5.12 Resource qualification manifest
5.13 Product definition
5.14 Production response
5.15 Production request
5.16 Control recipe
5.17 Recipe element
5.18 Master recipe
6 Completeness, compliance and conformance
6.1 Completeness
6.2 Compliance
6.3 Conformance
6.4 Extending the object model
Annex A (informative) Data modelling technique
Annex B (informative) Questions and answers