Good Distribution Practices News


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.



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.



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.



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.



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.



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



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



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 



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.



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.


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