http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/ All GDP guidelines in one single place! Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!

1. www.coldchainiq.com
A One Page Good Distribution Practice (GDP) is the part of quality
assurance which ensures that products are consistently
Guide to
stored, transported and handled under suitable IATA v
condition as required by the marketing authorisation r Chapter 17 “Air Transport Logistics for
Time and Temperature Sensitive
(MA) or product specification. There is no single global
Global GDP
Healthcare Products”
GDP standard. Cold Chain IQ has created this easy- IATA Perishable Cargo Regulations (PCR)
to-assimilate summary of GDP requirements around
Guidelines the world, enabling you to navigate the landscape. You
can keep it as a handy reference, share it around your
colleagues or even stick it on your wall!
european commission
r Commission Guidelines on Good
Distribution Practice of Medicinal Products
china
r Coming Soon: The newly revised Good
Supply Practice for Pharmaceutical
Products (GSP) will go into effect as of
for Human Use, 2011
r Guidelines on Good Distribution Practice June 1, 2013
KEy of Medicinal Products for Human Use State Food and Drug Administration, P.R.
uk r The principles of GDP are stated in China (SFDA)
Cick for more information r Guidance in the Transportation of Medicinal Directive 92/25/EEC
Products, ambient and refrigerated European Medicines Agency (EMA)
Medicines and Healthcare products
Regulatory Agency (MHRA)
canada
r Guidelines for Temperature Control of
denmark
r Executive Order No. 823 (IDRAC
Drug Products during Storage and ireland 148449): Distribution of Medicinal India
Transportation (GUI-0069) r IMB - Medicinal Products (Prescription Products, August 2012 r Guidelines on Good Distribution
Health Canada and Control of Supply) (Amendment) Danish Health and Medicines Agency Practices for Biological Products
Regulations 2007 (SI 201 of 2007)
r DRAFT: Guidelines on Good Distribution
r IMB Guide to Control and Monitoring of
united states Storage and Transportation Temperature
Practices for Pharmaceutical Products
Central Drugs Standard Control
r USP General Chapter <1079> Good
Storage and Shipping Practices
Conditions for Medical Products and
Active Substance
Worldwide Organization (CDSCO)
WHO v
r USP General Chapter <1083> Good Irish Medicines Board (IMB) r Good Distribution Practices for
Distribution Practices—Supply Chain pharmaceutical products TRS No. 957,
Integrity Annex 5 (2010)
United States Pharmacopeia (USP) r Model requirements for the storage and
transport of time and tem-perature
sensitive pharmaceutical products TRS singapore
No. 961, Annex 9 (2011) r DRAFT Guidance notes on Good
World Health Organization (WHO) Distribution Practice
Health Sciences Authority (HSA)
Brazil IPEC Europe v
r Opens public consultation on GMP r The IPEC –Europe Good Distribution
and GDP Requirements on January 15. Practices Audit Guideline FOR
Deadline for comments March 12, 2013 PHARMACEUTICAL EXCIPIENTS 2011
The National Health Surveillance Agency International Pharmaceutical Excipients
(Anvisa) Council (IPEC)
PDA v
Argentina r PDA Technical Report TR 52 (Aug 2011)
r ANMAT Ley 26.492, Regulación
Guidance for Good Distribution Practices
(GDPs) for the Pharmaceutical Supply
Australia
de la cadena de frío de los r Australian code of good wholesaling
Chain
medicamentos, 2009 practice for therapeutic goods for
r PDA Technical Report TR 53 Guidance
National Administration of Drugs, Foods human use
for Industry: Stability Testing to Support
and Medical Devices (ANMAT) Therapeutic Goods Administration (TGA)
Distribution of New Drug Products
r PDA Technical Report TR 58 Risk
Management for Temperature-
This information is accurate to the best of the respondents knowledge at that time, and may subsequently have changed. Cold Chain Controlled Distribution
IQ cannot take responsibility for the accuracy of this information. Reference: David Ulrich presentation “Good Distribution Practices Parenteral Drug Association(PDA) Connect to a cold chain
(GDP‘s) & Pharma Supply Chain Management” at the 2011 PDA Pharmaceutical Cold Chain Management Conference. IQ social network