Good Distribution Practices News


The ECA and the PQG publish two draft chapters on GDP interpretation

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline. Please find more here.



FDA Launches Secure Supply Chain Pilot Program

With a new program, the FDA intends to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States. Read more.



New EMA Inspection Requirements on Good Distribution Practices (GDP)

On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Read more details here.



EudraGMP Database now also comprises GDP Information

The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). Read more.



Final Good Distribution Practices (GDP) Guideline published by EU Commission

The long awaited EU GDP Guidelines was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03).  Click here to read more.



China Publishes New Good Distribution Practices

The Chinese Ministry of Heath (MOH) published on 22 January 2013 new requirements on Good Distribution - respectively on Good Supply Practice for Pharmaceutical Products. The new regulations apply not only to distributors but also to pharmaceutical manufacturers. Read more here.



Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline

The EU Commission has published a draft guideline on Good Distribution Practices for APIs. The GDP regulations for distributors and distributing companies partly contain very strict requirements. Read more here.



Draft Guideline on Good Distribution Practices for Biological Products published by CDSCO

The Central Drugs Standard Control Organization (CDSCO), the Indian Authority for Medicinal Product published a draft Guideline on Good Distribution Practice (GDP) for biological products. Read more.



The new EU Good Distribution Practices (GDP) Guideline - What will happen next?

In order to change the "old" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version on 15 July 2011. The EU Commission received a large number of comments from stakeholders. But what are the next steps? Please find more in our GMP News.



Audit Tools and Checklists for Good Distribution Practices

Warehouses and Distribution Facilities must be monitored very carefully. In order to assist the industry in meeting growing requirements, a new white paper and further documents have been published by Rx-360. Click here to read more.



New USP Chapter <1083> on Good Distribution Practices

In the USP Pharmacopeial Forum, you can find a new general chapter on "Good Distribution Practices - Supply Chain Integrity". The main issue focuses on measures to be taken against counterfeit medicines ("Best Practices to combat Counterfeit Drugs and Medical Devices") and actions to avoid theft during transportation ("Good Trucking Security Practices"). Read more in the News.



The new role of the Responsible Person for Good Distribution Practices

The new GDP Guideline is intended to come into force in June/July 2012. The key function of the so called Responsible Person will be strengthened. Please read more here.



EU Commission publishes Feedback on New Good Distribution Practices (GDP) Guide

The guidelines on Good Distribution Practice have been thoroughly revised and published for comment by the EU Commission on 31 December last year. Each single comment can now be consulted on the Commission website. Read more here.



Good Distribution Practices (GDP) adopted by PIC/S

Good Distribution Practice aspects have now found their way into the Pharmaceutical Inspection Co-Operation Scheme (PIC/S). Read more.



IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients

The IPEC Good Distribution Practice (GDP) Audit Guideline for Pharmaceutical Excipients has been revised and the new version has been published.  Plese find more information here


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