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.
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.
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.
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
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.
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.
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.