GMP News - APIs and Excipients


Revision or Renewal of CEPs: Requirements for Notifications to the EDQM

The EDQM has to deal with an increasing number of deficiencies in the notifications regarding revisions or renewals of CEPs which makes the procedure inefficient and which could be easiliy avoided. Here you can read more about the most common deficiencies found in the documents submitted to the EDQM.



Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010. Click here to read more.


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