EDQM updates Guideline on the "Requirements for revision/renewal of CEPs"

The holder of a Certificate of Suitability has to inform the EDQM of any change made to the information mentioned in the CEP application to avoid any risk regarding the validity of the CEP. The procedure for a change notification and the classification of changes are laid down in a guideline which was updated on 1st August 2014. The document is entitled "Guideline on the requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 6R".

The adjustment of this guideline had become necessary to take into consideration the requirements of two regulations which had been published in the meantime:

  • The EU "Guideline on Stability testing for applications for variations to a marketing authorisation", (EMA/CHMP/CVMP/QWP/441071/2011 Rev 2) dated 21 March 2014 (see our News from 23 April 2014) and
  • The EDQM Guideline "Use of a CEP to describe a starting material in an application for another CEP", (PA/PH/CEP (14) 06) (see our News from 8 July 2014).

The updated EDQM document contains - in accordance with the provisions of EMA's Stability Guideline from March 2014 - the requirement that, if available - supporting stability data should be submitted for the following scenarios:

  • Change in the manufacturer of a starting material or intermediate used in the manufacture of the final substance; or, change in the manufacturer of the final substance (if relevant, including quality control testing sites). The new manufacturer uses a substantially different route of synthesis or manufacturing conditions (i.e. new reagents, solvents, etc ...) which are likely to change the quantitative and/ or qualitative impurity profile of the final substance.
  • Change in the manufacturing process of a starting material, intermediate or final substance. The manufacturing process largely differs from the current one and/or, additionally an alternative process is performed. New reagents, solvents or materials are used. Changes in the qualitative and/or qualitative impurity profile are likely to happen.
  • Another immediate packaging for the final substance (sterile product) is used.

According to the EDQM terminology, all those changes are classified as "Major Changes" with potential influence on the quality attributes of the API.

Chapter "4.IV. Use of CEP in an application for another CEP" reproduces the specifications from the EDQM Guideline named above dated May 2014. It addresses the changes categories and the documentation requirements in cases where the CEP of a starting material is used for the application of a CEP for an API.

For a direct comparison, you can find here the previous (currently still valid) document (Version 5R).

The revised EDQM Guideline is coming into force on 1st October 2014.


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