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 (Inspections)

(21/05/10) The inspection fees for each inspection of an individual site initiated by EDQM will depend on the number of days taken to carry out the inspection. Typically an inspection lasts 3 days and costs 5 000 Euros. For shorter durations, the fees are indicated in the respective document (Certification Registration Fees). These fees are independent of the nature of the product and the type of manufacturing operation being inspected.

The inspection fees will be 9 000 Euros for an inspection of a site requested by a company, regardless of the length of time taken to carry out the inspection.

The EDQM charges companies the travel and accommodation expenses in addition to the inspection fee. Companies are also requested to take charge (organisation and costs) of transfers from/to the hotel and from/to the manufacturing site, for inspectors and any experts involved in the inspection.

The EDQM will send an invoice to the company. Full payment is due within 30 days of the date of the invoice. Several payment options are possible: by credit card online via the EDQM Store, by bank transfer and cheque.

Changes to the submitted documentation no longer accepted during the assessment phase

(15/04/10) As part of our ongoing efforts to shorten the processing time of CEP applications and ensure adherence to published deadlines, it has been decided to no longer accept changes or additions to submitted documentation under assessment which are not a consequence of a request for additional information. In effect, following the implementation of the two round policy from September 2008 onwards it has been noted that changes to the original documentation represent a significant part of evaluation of additional information. In addition, submission of changes at this moment also presents a risk that the changes are not explicit or not fully documented which may then also lead to further deficiencies and ultimately the rejection of the application or, at minimum, delays in issuing the CEP. This decision is effective as of 19th April 2010. As a consequence, any change to the application dossier not a consequence of a request for additional information will need to be immediately declared as a variation once the CEP has been issued. Exceptions to this new policy will include administrative notifications (e.g. change of names of companies) as well as any reply to a request for additional information sent following the introduction of a revised monograph.

Changes in contact details to be notified to EDQM

(15/04/10) In addition, applicants should remember that it is their responsibility, as applicant, to update the details of the contact person for their dossier. In fact, there are an increasing number of cases (affecting more and more applications) where the contact person for the application has been changed without EDQM being notified. This is the person to whom all communication about the application will be sent. In the event of non-receipt of any communication (e.g. person has left the company, personal contact details have changed etc.) the ensuing delays in response may lead to closure of the application due to non-response on the part of the applicant.

Actions taken by the EDQM

The EDQM announces the suspension of the following CEPs :

As a result of an inspection of the manufacturing sites:

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

As failure to commitments of willingness to be inspected (refusal of inspection, reconstruction/restoration of sites to achieve GMP level, temporary closure of a site...) and/or to operate according to EU GMP:

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 the API under the approved conditions:

Date

Substance name

CEP Number

No certificates recently suspended.

The EDQM announces the withdrawal of the following CEP:

As a result of an inspection of the manufacturing sites:

Date	Substance name	CEP Number
26/02/10	Propyphenazone	CEP 2001-041
26/02/10	Phenazone	CEP 2001-042
26/02/10	Metamizole sodium	CEP 2001-220

As failure to fullfil, after a suspension, the requirements of the CEP procedure with regards to the updating of the application and compliance with GMP:

Date	Substance name	CEP Number
12/07/10	Ceftriaxone Sodium	CEP 2000-017
12/07/10	Cefuroxime Sodium	CEP 2004-050

Events

Additional Information and Downloads

The Certification Division is pleased to announce that a certain number of its procedures and guidelines are now available in Chinese language.

List of all assessors (Updated 26/07/10)

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