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WHO: "Good distribution practices for pharmaceutical products"
06-02-2010 , WHO
This is the final version of the updated guideline for implementation of WHO Technical Report Series, 957, 2010, Annex 5, 236-264, covering good distribution practices for pharmaceutical products.
Document : WHO GDP 2010 Annex 5 TRS957_2010.pdf

PDA Technical Report 46, January 2010 (TR46)
01-01-2010 , PDA (Parenteral Drug Association)
This Technical Report from the PDA, titled "Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User", focuses on providing guidance "on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain".

WHO: "Good Distribution Practices For Pharmaceutical Products Including Measures Against Penetration Of Counterfeits Into The Legitimate Supply Chain"
09-17-2008 , World Health Organization
Following the adoption of the WHO guideline for good distribution practices (GDP) by the Fortieth WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2005 this guideline has been revised by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) partnership.
Document : GDP_counterfeits_QAS08_252_11012008.pdf

PDA Technical Report 39, Revised 2007 (TR39)
01-01-2007 , PDA (Parenteral Drug Association)
This revised report is one of the key documents providing guidance to the pharmaceutical industry on cold chain qualification.

USP General Chapter <1079> Good Shipping and Storage Practices
01-01-2007 , USP (United States Pharmacopeia)
This document from the United States Pharmacopeia (USP) is another key document providing guidance to the pharmaceutical industry on cold chain qualification.

IATA Perishable Cargo Regulations (PCR) Manual
01-01-2007 , IATA
"IATA’s Perishable Cargo Regulations (PCR) manual has become the world standard for the preparation, packaging and handling of time- and temperature-sensitive goods. Applying to all IATA member airlines, the PCR is the new leader in Cold Chain Management for pharmaceutical products and non-hazardous biological material. Not only will it provide you with the most efficient practices for your shipping of perishable cargo throughout the entire supply chain, but it will also answer all your questions regarding urgent time- and temperature-sensitive shipping". IATA

Irish Medicines Board: "Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances"
03-28-2006 , Irish Medicines Board
The purpose of this document is to provide guidance to medicinal product manufacturers (Human and Veterinary), wholesalers and transporters of human medicinal products in Ireland and manufacturer’s of Active Pharmaceutical Ingredients (APIs) in relation to conditions for cold storage / cold chain and controlled temperature storage. This guide does not purport to be an interpretation of the law and/or regulations relating to cold chain temperature and is for guidance purposes only.
Document : Guide for trans of med 194333_IND_003_01.pdf

Stability Testing of New Drug Substances and Products Q1A (R2)
02-28-2006 , International Conference on Harmonization
This document from ICH (International Conference on Harmonization), for technical requirements for registration of pharmaceuticals for human use, provides stability testing guidelines, relative to established climatic zones. A definition for Mean Kinetic Temperature is provided, as well as verbiage on storage condition tolerances.
Document : ICH Q1A R2.pdf

Australian Government: "National Vaccine Storage Guidelines"
11-22-2005 , Australian Government
This document is aimed at Australian vaccination service providers as a concise, practical user guide to vaccine storage. This document replaces "Keep it Cool" (2nd edition, 2001).
Document : strive-4-five.pdf

Health Canada: "Guidelines for Temperature Control of Drug Products during Storage and Transportation"
10-17-2005 , Health Canada
This document, Guide-0069, discusses Health Canada's guidelines for Temperature Control of Drug Products during Storage and Transportation.
Document : Health Canada Cold Chain.pdf


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