Certification of Suitability to the Monographs of the European Pharmacopoeia: News & General Information

Certification Monthly Report of Activities

(14/05/12) The Certification of Substances Division (DCEP) will publish on a monthly basis, a report containing some relevant figures relating to its main activities. April 2012 Certification Monthly Report

Conference on the certificate of suitability procedure

(02/04/12) To celebrate the 20^th anniversary of its Certification of Suitability to the Monographs of the European Pharmacopoeia Procedure, the EDQM of the Council of Europe organised an international conference on 22-23 March 2012 in Larnaca, Cyprus. The conference was opened by Mr. George L. Antoniou, Registrar Drugs Council, Pharmaceutical Services, Ministry of Health of the Republic of Cyprus, and was attended by 157 delegates from 35 countries representing all regions of the world.

Cases of falsification of data in the context of the CEP procedure

(29/03/12) In the framework of the EDQM inspection programme for companies who have requested or are holders of a Certificate of Suitability to the European Pharmacopoeia monographs (CEP), inspectors have come across several cases where data had been falsified, in some cases extensively and even systematically. The falsifications consisted of deliberately altering or creating data; be it in the CEP application, in batch records or any other records in order to hide a gap in information between the records and the true state of affairs.

In case of critical/major deficiencies in GMP or in CEP dossiers, the Certification Ad Hoc Committee usually decides to temporarily suspend CEP(s). However, in such particularly serious cases, the Ad Hoc Committee has decided to immediately withdraw the CEP(s) concerned. To date, four companies have been the subject of such decisions.

Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers - Terms of reference

(05/03/12) The EDQM has been involved in the international API Inspection Pilot Programme since its inception by the EMA at the end of 2007.

This programme, which now has become routine since 2011, involves inspection authorities from the US, Australia and Europe, as well as the EDQM, and is aimed at optimising inspection resources through the exchange of information and the performance of joint inspections. The terms of reference have been published by the participating organisations.

Please read the "Terms of Reference"

How to communicate with EDQM Certification Division

(15/02/12) In order to facilitate communication between the EDQM Certification Division (DCEP) and applicants and also to clarify the ways to send documentation, the DCEP has prepared a guideline that underlines the different possibilities for communication being proposed to companies. Please read ‘Communication with EDQM Certification Division’ / PA/PH/CEP (11) 70 for more information.

CEP Suspensions

a) Following inspection of the manufacturing site(s):

Date	Substance name	CEP Number
08/02/12	Quinine hydrochloride	CEP 2005-114
08/02/12	Quinine sulfate	CEP 2005-117
08/02/12	Digoxin	CEP 2009-281
08/02/12	Reserpine	CEP 2010-041
08/02/12	Colchicine	CEP 2011-016
07/02/12	Erythromycin	CEP 2009-267
07/02/12	Trimetazidine dihydrochloride	CEP 2007-245
20/12/11	Azathioprine	CEP 2001-341
20/12/11	Ticlopidine Hydrochloride	CEP 2003-066
20/12/11	Haloperidol	CEP 2003-206
20/12/11	Risperidone	CEP 2004-135
20/12/11	Diphenoxylate Hydrochloride	CEP 2005-084
20/12/11	Nifuroxazide	CEP 2006-074
04/11/11	Isosorbide mononitrate, dilute	CEP 2002-104
04/11/11	Protamine sulfate	CEP 2000-162

b) Due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure):

Date	Substance name	CEP Number
22/02/12	Theophylline	CEP 2004-139
22/02/12	Theophylline-ethylenediamine anhydrous	CEP 2004-140
22/02/12	Caffeine	CEP 2000-366
20/12/11	Troxerutin	CEP 2006-153

c) Upon request from the holder, due to a temporart inability to produce the API under the approved conditions

Date	Substance name	CEP Number
	None

CEP Withdrawals

a) As a result of an inspection of the manufacturing site(s):

Date	Substance name	CEP Number
08/02/12	Quinine sulfate	CEP 2009-387
08/02/12	Quinine hydrochloride	CEP 2010-069

b) Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP:

Date	Substance name	CEP Number
	None

Restoration of suspended CEP

Date	Substance name	CEP Number
01/03/12	Pyrazinamide	CEP 2000-036
01/03/12	Zopiclone	CEP 2001-203
01/03/12	Isoniazid	CEP 2008-108

Events

7th Edition European Pharmacopoeia Training Session (Chemicals), 9-10 July 2012, Strasbourg, France

CEP Suspensions, Withdrawals & Restorations

Read the updates on the latest CEP suspensions, CEP withdrawals and CEP restoration.

Additional Information & Documentation

List of all assessors (Updated 01/02/2012)

EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R2

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