In the recent three years many multinational unions agreed on common guidelines on Good Distribution Practice (GDP) or adopted a Mutual Recognition Agreement (MRA) of their national GDP regulations. Below we link these unions with their shared GDP guidelines. All the recently published GDP guidelines are very similar with few variations, e.g. the Gulf States require temperature monitoring at all times for pharmaceuticals. Below you find an overview of the co-operations with their guidelines and directives linked to the original documents.
Globally Valid GDP Guidelines
The Medicines and Health Products programme of the World Health Organisation (WHO) published 2010 the annex 5, titled “WHO good distribution practices for pharmaceutical products” in their Technical Report Series 957. This guideline is the minimum to follow for all and was the base for guidelines published after 2010.
Globally many countries’ authorities from AR (Argentina) to ZA (South Africa) follow the Pharmaceutical Inspection Co-operation Scheme (PIC/S). You find a list of all members participating, each with a link to the respective national authorities. The guideline itself, published 2014, is here: PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products.
Europe
In Europe, even in the non-EU-countries the European Commission on Medicinal products for human use published the last version of the guideline Good Distribution Practice of medicinal products for human use in November 2013 (direct link to pdf-download). Two years after, in March 2015 the European Commission Guidelines also published the Principles of Good Distribution Practice of active substances for medicinal products for human use, (direct link to pdf-download).
Eurasia
The Eurasian Economic Commission (members are Armenia, Belarus, Kazakhstan, Kyrgyz Republic and the Russian Federation) agreed 2015 on a common market of medicinal products and elaborated a range of documents e.g. regulating GMP and GDP. Their GDP guideline “On the Rules of good distribution practices of the Eurasian Economic Union” follows closely the guidelines of the European Commission and was published 2015.
China’s Food and Drug Administration amended its Good Supply Practice for Pharmaceutical Products in June 2016, but currently the new version is not published in English yet (Press release).
In the ASEAN countries the Pharmaceutical Product Working Group (PPWG) agreed on a mutual recognition arrangement (MRA) on GMP and GDP related inspections. Currently Singapore has the most elaborated “Guidance Notes on Good Distribution Practice” issued in 2015 and referring to the PIC/S guide, hence this guideline should be followed.
In the Gulf States the Executive Board of the Health Ministers’ Council for GCC States agreed 2014 on common “GCC Guidance for the Storage and Transport of Time- and Temperature–Sensitive Pharmaceutical Products”, which is far more restrictive than the e.g. the European guidelines.
Africa
Southern African Countries are united in the Southern African Development Community (SADC) Pharmaceutical Programme. Despite this, each country is still publishing its own guidelines, as e.g. South Africa’s Medicines Control Council which implemented in July 2016 the “South African Good Wholesaling Practice for Wholesalers”.
The Americas
In Central America most countries follow the GMP and GDP guidelines of the “Consejo de Ministros de Integración Económica Centroamericana” (COMIENCO), which can be downloaded on the site of the “Departamento de regulacion y control de productos farmaceuticos y afines” of Guatemala.
In the USA the U.S. Pharmacopeial Convention (USP) complements regulatory documents such as the FDA 21 CFR chapter 9. The USP revised the two general chapters, Good Storage and Distribution Practices for Drug Products [1079] and Good Distribution Practices for Bulk Pharmaceutical Excipients [1197] and included them in the general chapter “Good Distribution Practices—Supply Chain Integrity” [1083] .
Australia
Australia’s Government – Department of Health published 2011 a revised code of good wholesaling practice for medicines. Australia has a MRA with the European Union and also follows PIC/S.
We keep track of the changes and also of national guidelines which are sometimes still in force despite the superordinate guidelines of the trading unions. Contact us, if you need more information or an extensive catalogue of valid guidelines.
