Good Distribution Practices News


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



IMB publishes Guide on GDP (wholesale distribution)

On 29 September 2011, the Irish Medicines Board (IMB) published the Guide on wholesaling of medicinal products for human use in Ireland. Here you will find more.



Revised EU Guideline on Good Distribution Practice with major Changes

The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) published the draft of the revised 'Guideline on Good Distribution Practice of Medicinal Products for Human Use' for public consultation. The guideline has been completely revised. Read more.



New PIC/S Q&A Document regarding Distribution Activities for APIs

In March, the PIC/S published a Questions & Answers document which should provide support to inspectors in two areas: APIs Distribution/Supply Chain and Repackaging/Relabelling. Read more here.



EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use

The EU Commission has published a new Draft Guideline on Good Distribution Practice. This new takes into consideration the regulations of the Directive on Falsified Medicines and should replace the existing regulations which have been valid since 1994. What this implies for the pharmaceutical wholesale can be read here.



News IPEC-Americas "Distributors Audit Guide" for Pharmaceutical Excipients

IPEC Americas has published a new Distributors Audit Guide. The document was developped to support audits of API suppliers and their supply chain. European standards from the "Good Distribution Practices" and from the WHO were taken over. Read more here



WHO revises Good Distribution Practices for Pharmaceutical Products

With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also updated Annex 5 "WHO good distribution practices for pharmaceutical products". Read more about the changes.



New EMEA Concept Paper on the Revision of the EU Guideline Good Distribution Practices (GDP)

The European Medicines Agency (EMEA) has made plans for adaptations to the Good Distribution Practice Guideline (94/C 63/03). Read more about the concept.


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