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.
Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline
The EU Commission has published a draft guideline on Good Distribution Practices for APIs. The GDP regulations for distributors and distributing companies partly contain very strict requirements. Read more here.
The new EU Good Distribution Practices (GDP) Guideline - What will happen next?
In order to change the "old" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version on 15 July 2011. The EU Commission received a large number of comments from stakeholders. But what are the next steps? Please find more in our GMP News.
Audit Tools and Checklists for Good Distribution Practices
Warehouses and Distribution Facilities must be monitored very carefully. In order to assist the industry in meeting growing requirements, a new white paper and further documents have been published by Rx-360. Click here to read more.
New USP Chapter <1083> on Good Distribution Practices
In the USP Pharmacopeial Forum, you can find a new general chapter on "Good Distribution Practices - Supply Chain Integrity". The main issue focuses on measures to be taken against counterfeit medicines ("Best Practices to combat Counterfeit Drugs and Medical Devices") and actions to avoid theft during transportation ("Good Trucking Security Practices"). Read more in the News.
EU Commission publishes Feedback on New Good Distribution Practices (GDP) Guide
The guidelines on Good Distribution Practice have been thoroughly revised and published for comment by the EU Commission on 31 December last year. Each single comment can now be consulted on the Commission website. Read more here.