PDA Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution (single user digital version)
- Published
- Sep 2012
- ISBN
- 9780939459438
- Pages
- 73
- PDA Item Number
- 43499
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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The Risk Management for Temperature-Controlled Distribution Task Force has produced a comprehensive Technical Report that will help manufacturers and distributors apply risk management to distribution practices.
PDA Technical Report No. 58: Risk Management for Temperature-Controlled Distribution is meant to complement ICH Q9: Quality Risk Management, and is part of the series of good distribution technical reports produced by the PDA Pharmaceutical Cold Chain Interest Group, which has developed Technical Reports No. 39 (Cold Chain), 46 (Last Mile), 52 (GDPs) and 53 (Stability Testing).
The goals of risk management in the temperature-controlled distribution of pharmaceutical products, are to:
- Preserve the quality, safety and efficacy of the product
- Understand the distribution process
- Reduce risk
- Understand residual risk
- Improve the effectiveness of the process
Technical Report No. 58 provides specific guidance on the identification, assessment, evaluation, control and review of risks in the distribution process, such as receipt, storage, handling and shipping of bulk, intermediate and finished pharmaceuticals, biological medicinal products and medical devices. It also provides guidance for handling incidents, like temperature excursions, that occur during the distribution process.
The Appendix includes examples of five executed FMEAs for the distribution of products in temperature-controlled containers and thermal packouts and a description of Incoterm definitions.
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Temperature-Controlled Distribution Management
- Risk Assessment
- Risk Control
- Risk Review
- Appendices
- Additional Reading
- References
About the Authors
Erik J. van Asselt, Ph.D., Merck, Sharp & Dohme B.V. (MSD)
Henry Ames, Sensitech Inc.
Olav Berkelmans, Penske Logistics B.V.
Rafik H. Bishara, Ph.D., PDA Pharmaceutical Cold Chain Interest Group Leader (U.S. Branch)
Boriana Cavicchia, PRTM Management Consultants
Bent Christensen, Novo Nordisk A/S
Kelvin M. Chuu, Abbott Laboratories, Inc.
Margaret Clayton, Envirocooler
Mel Drews, Agility Logistics
Herbert Ernst, Ph.D., Sensitech
Richard C. Harrop, TOPA Verpakking
Geoffrey Glauser, Health and Human Services, ASPR
Maryann Gribbin, Johnson & Johnson
Ian King, Pfizer
Jonathan Neeld, CSafe
Eric A. Newman, Protecht Risk Solutions (a division of Falvey Cargo Underwriting)
Anthony Rizzo, Cold Chain Technologies
Jeffrey Simpson, Cold Chain Technologies
David A. Ulrich, Abbott Laboratories, Inc.
Sezer Aksoyak, Pfizer
Christine Andersson, Envirotainer AB
Bertrand Chassagne, AXA Corporate Solutions
Jim Correnti, Hapag-Lloyd
Alan J. Davis, Johnson & Johnson
Arminda Montero, Abbott Laboratories, Inc.
Neritan Mustafa, Genzyme
Patrick V. O’Laughlin, Merck & Co.
Gary Olsen, Fedex
Richard Peck, Softbox Systems
Martin Peter, Elpro-Buchs AG
Helena Sjöström, Envirotainer AB
Carsten Thiemt, Arvato Services Healthcare (Bertelsmann AG)
Arno van Klaveren, Air France KLM Cargo
Niels van Namen, DSV Solutions
Tony Wright, Ph.D., Exelsius