Good Distribution Practices News

03.01.12

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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21.12.11

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.

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10.08.11

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.

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10.08.11

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.

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20.07.11

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.

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30.03.11

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

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12.08.10

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.

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29.04.09

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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