PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (single user digital version)

Published
Sep 2020
ISBN
9781945584190
Pages
65
PDA Item Number
43547

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PDF Single user
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$325.00
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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.

Table of Contents

  Table of Contents:

Click here to download >>> Detailed 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

About the Authors

Els Poff, Merck

James Curry, PhD, Teva Pharmaceuticals

John Grealis, PhD, Novartis

Anne Pericone, Johnson & Johnson

Susan Schniepp, Regulatory Compliance Associates Inc.

Nader Shafiei, PhD, Sanofi

Ronald Tetzlaff, PhD, Parexel Consulting

Anthony Warchut, AC Warchut GMP Consulting

Jeffrey Broadfoot, Emergent BioSolutions, Inc.

Derek Glover, Mylan

Maryann Gribbin, Faith & Royale Consultants

Tina Morris, PhD, American Association of Pharmaceutical Scientists

Rebecca Parrilla, U.S. Food and Drug Administration

Carmelo Rosa, PsyD, U.S. Food and Drug Administration

Anil Sawant, PhD, Merck

Christopher Smalley, PhD, ValSource, LLC

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