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GMP Non-Compliance

Information is now publicly available via the EudraGMDP data base.

The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with Good Manufacturing Practice. Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health.

These statements aim to establish a coordinated and harmonized response by the network of European Union (EU) medicines regulators. Some non-compliance statements are the result of inspections carried out by the EDQM with the participation of EU/EEA national inspectorates. Any statement of GMP non-compliance that is related to a manufacturing site covered by a CEP application initiates the decision making process on the validity of the CEPs concerned by the EDQM, regardless of whether the EDQM has been involved in the inspection or not.

Information of a commercially or personally confidential nature is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.

 

Read the updates on the last six months:

 

CEP Suspensions

 

1.Upon request from the holder, due to a temporary inability to produce under the approved conditions

 

Date

Substance name

CEP Number

05/11/2019

Methyl salicylate

CEP 2004-060

 

2. Due to GMP non-compliance

 

Date

Substance name

CEP Number

03/01/20 Prednisolone acetate Micronised, sterile CEP 2017-286
19/12/19 Fluoxetine hydrochloride CEP 1999-071
19/12/19 Clindamycin hydrochloride CEP 2000-041
19/12/19 Clindamycin phosphate CEP 2000-097
19/12/19 Pethidine hydrochloride CEP 2003-087
19/12/19 Pethidine hydrochloride: For use in the manufacture of parenteral dosage forms CEP 2003-088
19/12/19 Zolpidem tartrate CEP 2005-193
19/12/19 Lamotrigine CEP 2010-382
19/12/19 Etofenamate CEP 2012-114
19/12/19 Ketorolac trometamol CEP 2015-190
19/12/19 Cyclopentolate hydrochloride CEP 2016-078
19/12/19 Omeprazole magnesium CEP 2016-087
19/12/19 Esomeprazole magnesium dihydrate CEP 2016-088
19/12/19 Valaciclovir hydrochloride CEP 2017-003
21/11/19 Metronidazole benzoate CEP 2007-056
05/11/19 Cefotaxime sodium, sterile CEP 2014-197
05/11/19 Cefuroxime sodium, sterile CEP 2014-021
 

3. Due to a failure to fulfil the requirements of the Certification procedure

 

Date

Substance name

CEP Number

27/01/20 Irbesartan CEP 2012-156
27/01/20 Irbesartan CEP 2014-029
08/01/20 Olmesartan medoxomil CEP 2012-239
08/11/19 Ranitidine Hydrochloride CEP 2001-228
30/10/19 Ranitidine Hydrochloride CEP 2007-320
11/10/19 Ranitidine Hydrochloride CEP 1996-102
11/10/19 Ranitidine Hydrochloride CEP 2000-342
11/10/19 Ranitidine Hydrochloride CEP 2002-075
11/10/19 Ranitidine Hydrochloride CEP 2017-068
19/09/19 Ranitidine Hydrochloride CEP 2004-057

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CEP Withdrawals

1. Due to GMP non-compliance

 

Date

Substance name

CEP Number

14/11/19 Erythromycin CEP 2009-267
14/11/19 Bisoprolol fumarate CEP 2013-342
 

 

2. Due to a failure to fulfill the requirements of the Certification Procedure

 

Date

Substance name

CEP Number

-

-

-

 

 

Restoration of suspended CEP

 

Date

Substance name

CEP Number

31/01/20 Amoxicillin trihydrate CEP 2007-315  
08/01/20 Amoxicillin trihydrate compacted CEP 2016-310
16/12/19 Valsartan CEP 2010-072
22/10/19 Valsartan Process III CEP 2016-069
15/10/19 Irbesartan CEP 2010-033 
15/10/19 Losartan Potassium CEP 2010-139
08/10/19 Valsartan CEP 2011-174
18/07/19 Losartan Potassium Form I CEP 2009-247

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