PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
- Published
- Feb 2025
- Pages
- 59
- PDA Item Number
- 60005
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is also applicable to aseptic processes used to manufacture sterile products, terminally sterilized products, as well as low bioburden processes in the manufacture of regulated healthcare products. It is applicable to pharmaceutical, biological, and ATMP (Advanced Therapeutic Medicinal Products) products. This standard does not supersede or replace regulatory requirements, such as Current Good Manufacturing Practices (CGMPs) and/or compendial requirements that pertain to a particular national or regional jurisdiction.
Table of Contents
1. Introduction
2. Scope
3. Terms and Definitions
4. Acronyms /Abbreviations
5. Fundamental Principles of Quality Risk Management
6. Quality Risk Management Method for Aseptic Processes
7. Bibliography/ References
Appendix A: Preventive Controls Ratings and Criteria.
Appendix B: Detection Mechanisms Ratings and Criteria
Appendix C: Improvement Priority Matrix
Appendix D: Case Study
About the Authors
Noel Long (Chair) Cytiva, formerly GE Healthcare
Amanda Bishop McFarland (co-Chair), ValSource, Inc.
Kristen Anderson, U.S. Food and Drug Administration
Fred Ayers, ValSource, Inc.
Hal Baseman ValSource, Inc.
Jette Christensen* Novo Nordisk
Darla Erma, CSL Behring Biotherapies for Life
Aidan Harrington, Arcadis
Andreas Skovgard Jacobsen, Novo Nordisk
John Kutney, Novavax
Ivy Louis, Vienni® Training & Consulting LLP
Patrick Mains, ValSource, Inc.
Erika Pfeiler, U.S. Food and Drug Administration
Anne V. Renton, Eli Lilly and Company
Ed Tidswell, Merck
Robert Tomaselli, RPT Medical Products Consulting LLC
Rajyalakshmi Vathyam, Takeda Pharmaceuticals
Kelly Waldron, ValSource, Inc. / Technological University of Dublin
* In memoriam Jette Christensen a contributor and a great member of this scientific community who unfortunately passed away before this standard was published.