PDA Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain (single user digital version)
- Published
- Aug 2011
- ISBN
- 9780939459339
- Pages
- 36
- PDA Item Number
- 43491
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including handling, storage, transportation and distribution. It applies to all parties involved, including, but not limited to, the manufacturer, the holder of the marketing authorization, third party Logistics Service Providers (termed 3PLs), wholesale distributors, and transportation carriers.
Anyone involved with the shipping and distribution of pharmaceutical products will benefit from Technical Report No. 52: Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain.
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Table of Contents
Table of Contents:
Click here to download >>> Table of Contents
- Introduction
- Glossary of Terms
- Requirements
- Appendix
- Additional Reading
About the Authors
Rafik H. Bishara, (ret.) Ph.D., PDA Pharmaceutical Cold Chain Interest Group Leader
Stephanie Bradley, Siemens Healthcare Diagnostics, Inc.
Bella R. Cohen, Ph.D., Abbott Laboratories
Emily Badraslioglu, Department of Health and Human Services
Larry A. Gordon, Cold Chain Technologies
Maryann Gribbin, Johnson & Johnson (co-Task Force Leader)
Karl I. Kussow, FedEx Custom Critical
Gerry Marasigan, SNC Lavalin Pharma
Elaine Merritt, Johnson & Johnson
Arminda O. Montero, Abbott Laboratories, Inc.
Johan Nordenberg, Envirotainer AB
Jeff Seeley, JLS Distribution Packaging, LLC
Elyse Smith, Meridan Consulting, LLC
David Ulrich, Abbott Laboratories (co-Task Force Leader)