change of the manufacturer of a starting material

1、https:/www.edqm.eu/site/faq_traitement_reponse.php?idMessageOuvert=43539MY MESSAGE BOX( R e f r e s h )HelpDesk and publications registration webpageNQuestionsDateStatusQ43539Change/addition of the manufacturer of a starting material07/12/2010 09h18 TreatedQuestion 1 (07/12/2010 09h18) :Name: Fengmi

2、ng.Firstname: Jing.Organisation / Company: Suzhou No.4 Pharmaceutical Factory.Job title: Vice Manager of RA.Address: 171 Baiyangwan Street.Postcode: 215008.Town: Suzhou.Country: China.Phone: 0086-(0)512-65334311.Fax: 0086-(0)512-65560866.Message:Dear Sir or Madam:Our Clindamycin Hydrochloride CEP nu

3、mber is R0-CEP 2005-287-Rev 00 and Clindamycin Phosphate CEP number is R0-CEP 2007-250-Rev 01. The Lincomycin Hydrochloride is the starting material of Clindamycin Hydrochloride and Clindamycin Phosphate.The starting material Lincomycin Hydrochloride is manufactured by our factory and the CEP of Lin

4、comycin Hydrochloride is held by Pfizer Inc, which is authorized by our factory, the CEP number is R0-CEP 2005-284-Rev 01.Now Our factory wants to change/add the manufacturer of a starting material and my first question is that if the new supplier shoud be the CEP holder and pass the EDQM inspection

5、? if the new supplier only passed the FDA inseption, could we choose it as the supplier?My second question is that the new supplier is only the CEP holder,if we choose it as supplier,then EDQM would inspect the new supplier?My third question is that if I choose the CEP holder from china as the suppl

6、ier, then do I need the LOA from CEP holder?The last question, if we change/add the manufacturer of a starting material, it should be a major change,then what should we do? What kind of specific documentation do we need to provide ?I would appreciate it if you can give us some details. Thanks!Respon

7、se 1 (08/12/2010 15h03) :Dear Mr Fengming,If you wish to change / add a new supplier of starting material under the conditions of a major change ( MAJ 1) you will be requested to compare in synthetic routes of approved and proposed sources. The potential carry-over of any new solvent/ reagent/ catal

8、yst/ impurity should be discussed and supported by analysis data as necessary ( using suitably validated methods). Complete comparative API batch data should also be provided.In case the proposed source is covered by a CEP you should provide copy of the letter of access.Finally please note that the

9、introduction of an additionnal source of starting material has no direct consequence on the potential inspection of a site covered by a CEP.I hope this clarifies the situation,Yours sincerely,Ms Florence SchuliarCertification DivisionEDQMCouncil of Europe第1页 共2页2010-12-9 08:39 上午https:/www.edqm.eu/s

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