PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic-based, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report.

This technical report describes an approach using quality risk management (QRM) for establishing and assessing the appropriateness of data integrity controls for each manufacturing operation based on the criticality and vulnerability of the data for its intended use.

Developed by subject matter experts from global industry and regulatory agencies, TR 84 summarizes manufacturing data integrity risks and identifies best practices that can be used to develop and sustain robust documentation, as well as data integrity management procedures, systems, processes, and controls. Employing these practices will help users achieve compliance with applicable laws, regulations, and directives for pharmaceutical products such as active pharmaceutical ingredients (APIs), solid oral dosage forms, sterile injectables, biologics, and vaccines.

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  Table of Contents:

1. Introduction and Scope
2. Glossary and Abbreviations
3. Data Integrity Trends at International Drug Manufacturers
4. Quality Risk Management Applied to Data Integrity
5. Data Integrity Controls
6. Controls for Big Data as it Relates to Data Integrity
7. References
8. Annex 1: Examples — How to use the 9-Box Vulnerability Grid

Figures and Tables Index