EMEA Plans Changes in the Field of GMP-Compliant Manufacturing of Investigational Medicinal Products

GMP News No. 707

GMP News
19 April 2006
 

EMEA Plans Changes in the Field of GMP-Compliant Manufacturing of Investigational Medicinal Products

 
On 24 March 2006, EMEA published a working plan of the working groups for GCP and GMP inspection services. In the months to come, EMEA intends to advance a whole number of activities concerning the GMP-compliant manufacture of investigational medicinal products. Among them are the following:
  • Working out questions and answers in order to clarify/explain point 42 of Annex 13 (special regulation for packaging and labelling). This includes the assimilation of the requirements laid down in Directive 2005/28/EC (Article 9.2).
  • Determining the content of the "Batch Release Certificate"
  • Adapting Annex 13 with regard to the new Annex 19 on retention and reference samples
  • Creating a guidance on transport and storage conditions for investigational medicinal products (IMPs)

What is particularly interesting is the fact that the EMEA intends to analyse the draft guidance on GMP requirements in clinical phase I recently published by the FDA. In doing so, the authority wants to evaluate in how far the EU should adapt its own GMP requirements on the early stages of clinical trials. Read the details of this FDA initiative in our GMP news of 9 February 2006.
 

Forthcoming events in the fields of development/investigational medicinal products:

GMP Webinar: 29 May 2006, 13:30 - 15:00 h (CEST) – with Dr Joerg Neuhaus, District Government of Cologne
GMP in Early Phases of Development - Focus on Biopharmaceuticals

GMP-Compliant Development of Biopharmaceuticals - With Site Visit at CMC Biopharmaceuticals
15-17 May 2006, Copenhagen, Denmark

 
Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

Source: EMEA web page – http://www.emea.eu.int/Inspections/docs/GcmPwp2006.pdf
 

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