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Certification of Suitability to the Monographs of the European Pharmacopoeia: News & General Information
List of Top Ten Deficiencies found during the First Assessment of New Applications
From October to December 2009
(27/07/10) A summary of the main deficiencies found in the dossiers for Certificates of Suitability (CEP) assessed from October to December 2009 is now available. By including these recommendations together with the requirements described in the EDQM Guideline "Content of the dossier for chemical purity" (PA/PH/CEP (04) 1 4R), applicants can improve the quality of their dossiers with a view to facilitating and speeding up the granting of their CEP.
TOP TEN DEFICIENCIES New applications for CEPs (End 2009) PA/PH/CEP (10) 65
Fees & Financial Provisions For Inspections
(21/05/10) The fees for an individual site inspection initiated by the EDQM depend on the number of days taken to carry it out. Typically, an inspection lasts 3 days and costs 5,000 Euros. For shorter durations, the fees are indicated in the document "Registration Fees". They are independent of the nature of the product and the type of manufacturing site being inspected.
For a site inspection requested by a company, the inspection fees are 9,000 Euros regardless of the time taken to carry it out.
In addition, the EDQM charges companies for its travel and accommodation expenses. Companies are also requested to pay the costs of and to organise transfers, for the inspectors and any experts, to and from the hotel and the site.
The EDQM sends an invoice. Full payment is due within 30 days of its date. Several payment options are possible: payment by credit card via the EDQM Online Store, by bank transfer and by cheque.
Events
No upcoming events.
CEP Suspensions:
Following inspection of the manufacturing site(s):
| Date | Substance name | CEP Number |
| 08/07/10 | Flunarizine Dihydrochloride | CEP 2004-142 |
| 08/07/10 |
Loperamide Hydrochloride |
CEP 2005-247 |
| 08/07/10 |
Cinnarizine |
CEP 2007-257 |
| 31/03/10 |
Chlorpropamide |
CEP 2000-020 |
| 31/03/10 |
Tolbutamide |
CEP 2000-021 |
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 |
| 09/07/10 | Oxytetracyline Dihydrate |
CEP 2004-177 |
| 09/07/10 |
Oxytetracyline Hydrochloride |
CEP 2008-165 |
Due to a temporary inability to produce API(s) under the approved conditions:
No certificates recently suspended.
CEP Withdrawals:
As a result of an inspection of the manufacturing site(s):
No certificates recently withdrawn.
| Date | Substance name | CEP Number |
| |
|
|
Due to a failure to fulfill, after a suspension, the requirements of the CEP procedure with regards to updating the application and complying with GMP:
| Date | Substance name | CEP Number |
| 12/07/10 |
Ceftriaxone Sodium |
CEP 2000-017 |
| 12/07/10 |
Cefuroxime Sodium |
CEP 2004-050 |
Additional Information & Documentation
List of all assessors (Updated 26/07/10)
EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R1
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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