ISA 88.00.04 : 2006

1 Scope
2 Normative references
3 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 Modeling 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 modeling technique
Annex B (informative) - Questions and Answers
List of Figures
List of Tables

ISA-88.00.04-2006, Batch Control Part 4: Batch Protection Records, defines a structured reference model for batch production records in batch manufacturing processes. It provides detailed descriptions and an object model for the contents of batch production records, including execution and business information related to batch production.


This standard supports consistent data storage, exchange, retrieval, analysis and reporting across multiple systems and industries, in regulated sectors like pharmaceuticals. It outlines the structure, elements, attributes and relationships within batch production records, covering aspects such as events, data sets, samples, personnel identification, resource qualifications, recipes and production requests/responses.


ISA-88.00.04-2006, Batch Control Part 4, also addresses data management concerns such as retention, integrity, lifecycle states and compliance with regulatory and business requirements. It serves as a comprehensive framework for developing technology-specific implementations that facilitate interoperability and improved communication among manufacturers, vendors and regulatory bodies.