Good Distribution Practices News

01.07.14

MHRA refers to the Gold Standard for Responsible Person

In our Newsletter we reported about a so called Gold Standard for the qualification of a Responsible Person for GDP. Now the MHRA cites the standard on their webpage. Read more about the Gold Standard.

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01.07.14

GDP Supplier Database

The Good Distribution Practice Group has been asked by its members to set up a supplier database. Click here to read more about the GDP Database

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14.05.14

Gold Standard for the qualification of a Responsible Person for GDP

The new EU GDP Guideline requires that a Responsible Person for GDP has been named. In the UK an organisation has published a "Gold Standard for a Responsible Person". Read more about the Gold Standard.

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07.05.14

GDP Question: When to use Mean Kinetic Temperature Calculation (MKT)?

The British Medicines Authority MHRA is performing GMP and GDP Inspections on a risk based strategy. Based on the experience the MHRA answers frequent asked questions. One very interesting Q&A refers to Mean Kinetic Temperature Calculations (MKT). Read more about MKT here

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30.04.14

ECA and PQG publish an additional chapter on the interpretation of the EU GDP Guide

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) have announced the availability of chapter 7 "Outsourcing" on the interpretation of the new EU GDP Guideline. Read more about the GDP interpretation.

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04.04.14

European Commission publishes Question & Answer Document on GDP

On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpreation of the new EU GDP Guideline. Please read more about the EU GDP Q&A Document

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12.03.14

EMA Database: First GDP Non-Compliance Report published

All GMP and GDP certificates are listed in a database by the European Medicine Agency. On 19 February 2014, the first wholesaler has been declared GDP non-compliant by the Czech authority. Read more here in the News.

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12.03.14

GDP: Q&As for Wholesale Distribution of Medicines

DHMA has recently updated its "wholesale distribution of medicines within the EU/EEA questions and answers" document. It gives some valuable information for those who distribute medicines in, from and to Denmark. Read more.

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05.03.14

FDA Secure Supply Chain Pilot Program: 13 companies prequalified

In August 2013, the FDA initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs. Now, the first companies have been listed. Read more.

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19.02.14

Transport Validation: new Considerations by Annex 15

The European Commission has launched the long expected draft of the revised Annex 15 (Qualification and Validation) for public consultation (see our news from 12 February). with a new chapter on verification of transportation. Read more.

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05.02.14

GDP Certificates: 677 in the EudraGMDP Database

The volume of the EudraGMDP database keeps on growing. Thanks to a search function, you can scan entries according to various criteria. Read more here about the EudraGMDP.

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15.01.14

Implementation of Good Distribution Practices: Explanatory Notes from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. Click here to read more

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08.01.14

USP proposal on temperature control during storage and distribution

The USP has published a so called stimuli article which is intended to provide a proposal to revise an existing USP monograph. The proposal intends to broaden the permitted range when appropriate for specific products. Read more in our GMP News

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11.12.13

New GDP Guide available in 22 different languages

The Good Distribution Practice Group (GDP Group) has summarized all language versions of the new GDP Guide. Please click here for more information 

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04.12.13

Guidelines on GDP revised

Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised. Read more.

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