Good Distribution Practices News

06.07.17

Comprehensive Overview on WHO Storage and Transportation Guidelines

The European GDP Association has now put together WHO's GDP documents to provide a better overview and easier access.

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02.03.17

New GDP Rules in Russia - what you need to know

From 1 March 2017 there are new GDP rules valid in Russia . All pharmaceutical companies distributing to Russia should be aware of the new Russian GDP regulations.

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02.03.17

What are the regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"?

What do storage requirements like, for example "ambient", "room temperature" and "cold chain" exactly mean? Worldwide, there are different definitions for these storage requirements.

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02.03.17

The GMP/GDP Interface: When the Inspector comes

Storage facilities are not only a hot topic in GDP inspections. GMP inspectors also make observations in these areas, as some examples show, which were published by the U.K. authority MHRA.

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19.01.17

Increasing Number of GDP Non-Compliance Certificates

The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. From January 2016 until today six GDP non-compliance reports have been published. Please read more about the GDP Non-Compliance reports.

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19.01.17

A 12 steps guide on how to choose the right Third Party Logistics (3PL) provider

Having in mind a proper needs assessment  many companies in the field are considering the outsourcing of their logistic activities. But when it comes to the decision making definite decisions are required. Support provides a 12-steps guide for the outsourcing of logistics activities.

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19.01.17

The Qualified Person: also responsible for Distribution Activities?

In his talk on "Detection of Falsified Medicines and how the QP can support this", Paul Hargreaves (MHRA), explored some facts that a QP should know when it comes to the falsification of medicines.

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19.01.17

Do you know the Saudi GDPs? And the Role of the Responsible Person?

The GDP Guidelines of the Saudi Food & Drug Authority (SFDA) have been published in English and are similar to those in the EU. But there are also some differences between the Saudi and the European GDP Guidelines.

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21.09.16

Current Status of GDP Implementation and the Role of the RP - an Overview

To find out where the EU GDP Guidelines have been implemented already as a national rule ECA's GDP Working Group set up a survey amongst its members. Here is a summary of the feedback.

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08.08.16

How to perform Temperature Mapping

In a recent blog of the MHRA, the inspectorate looks at temperature mapping. It seems that "some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines".

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08.08.16

Refrigerated Medicinal Products: Things to consider

Based on the experience made in GDP inspections, the MHRA has published things to consider for the transportation and temperature management of refrigerated medicinal products.

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08.08.16

GDP: MHRA concerned about Qualification of Customers

In a new blog, the MHRA reminds companies to qualify their customers. This should be done similar to the qualification of suppliers.

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14.07.16

Storage and Transport: New USP Chapter for Investigational Drug Products

The USP has proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters, focusing on investigational drug products.

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14.07.16

Example by Inspectorate for Handling Temperature Excursions

In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU.

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14.07.16

GDP: What is a Pre-Wholesaler?

The definition for "pre-wholesale" is neither present in the EU GDP guidelines nor in the GMP requirements from Eudralex. However, this concept does exist and some things have to be considered.

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