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 current Non-Compliance Reports

 

Read the updates on the last six months:

 

CEP Suspensions

 

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

Date

Substance name

CEP Number

01/06/2023

 Metoprolol succinate CEP 2010-109

 

Due to GMP non-compliance

Date

Substance name

CEP Number
19/09/2023                             Amoxicillin sodium CEP 1996-013
19/09/2023                             Flucloxacillin sodium monohydrate CEP 1999-039
19/09/2023                             Piperacillin sodium CEP 1999-117
19/09/2023                             Ampicillin sodium CEP 1999-169
19/09/2023                             Piperacillin sodium CEP 2006-252
10/08/2023 Ferrous gluconate hydrate CEP 1999-164
10/08/2023 Zinc gluconate CEP 2012-221
10/08/2023 Calcium glycerophosphate CEP 1996-106
30/03/2023 Hyaluronidase  CEP 2001-068

 

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

Date

Substance name

CEP Number

16/03/2023

 Terazosin hydrochloride dihydrate CEP 2006-307

 

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CEP Withdrawals

 

Due to GMP non-compliance

Date

Substance name

CEP Number
- - -

 

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

Date

Substance name

CEP Number
09/11/2023 Oxytetracycline hydrochloride CEP 2013-200
09/11/2023 Oxytetracycline dihydrate, process B CEP 2013-196
09/11/2023 Oxytetracycline dihydrate CEP 2011-079
22/09//2023 Ramipril CEP 2006-006
22/09//2023 Cefixime CEP 2008-124
22/09//2023 Lamotrigine CEP 2009-278
15/06/2023      Colchicine CEP 2002-062
11/04/2023 Bromazepam CEP 1998-150

Due to the deletion of the monograph from the European Pharmacopoeia

Date

Substance name

CEP Number
- - -


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Restoration of suspended CEP

 

Date

Substance name

CEP Number
31/08/2023 

Ranitidine Hydrochloride

 CEP 2017-068
05/04/2023

Metronidazole benzoate

 CEP 2007-056

 

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