PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
- Published
- Feb 2025
- Pages
- 57
- PDA Item Number
- 60006
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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This American National Standard (ANS) evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. The standard identifies 5 key focus topics with attributes, characteristics, and measurements that should be considered to effectively establish, measure, and maintain a mature quality culture as an important fundamental element of a robust quality management system. The five key focus topics were selected from the PDA Quality Culture Assessment Tool for their comprehensiveness.
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Table of Contents
1. Introduction
2. Scope
3. Relevant References
4. Terms and Definitions
5. Acronyms
6. Leadership Commitment
7. Communication and Collaboration
8. Employee Ownership and Engagement
9. Continuous Improvement
10. Technical Excellence
11. Bibliography
About the Authors
Susan Schniepp (Chair) Regulatory Compliance Associates, A Nelson Labs Company
Althea Micklewright (Co-Chair), Pfizer Inc.
Rebecca Walden (Co-Chair), Irish Blood Transfusion Service
Deepak Aggarwal, Biomedical Advanced Research and Development Authority (BARDA)
Vaishnavi Babu Apotex Inc., Apotex Research Private Limited
Denyse Baker, Eli Lilly and Company
Jeff Broadfoot, Emergent BioSolutions Inc.
Cylia Chen-Ooi, Amgen
Tais Helena Daronco, Conti Bristol Myers Squibb
Steffen Eich, Institute of Technology Management, University St. Gallen
Tami Frederic, Perrigo Company
Jeremiah Genest, Vertex Pharmaceuticals
Mark Grothkopp, Institute of Technology Management, University St. Gallen
Kelly Hadsall, Minnesota Board of Pharmacy
Chris Masterson, Tolmar
Caroline Offerle, European Directorate for the Quality of Medicines & HealthCare (EDQM)
Christine Teipen Smith, Eli Lilly and Company
Veda Walcott, Catalent Pharma Solutions
Steven Walfish, Statistical Outsourcing Services (Iovance)
Most Nahid Parvin, U.S. Food and Drug Administration (FDA)