cep_application_form_for_revision_and_renewal_of_cep.doc

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1、Application FormREQUEST FOR REVISION OR RENEWAL OF CERTIFICATE OF SUITABILITY(to be filled in for each request for revision or renewal of a Certificate of Suitability to the monographs of the European Pharmacopoeia, in accordance with ResolutionAP-CSP (07) 1)Date of submission: ./Format of submissio

2、n (select one only): eCTDNeeS PDF Paper1. General Information1.1 Dossier number and substanceCEP / Substance name Subtitle (if applicable) .In case of grouped revision (a revision affecting several CEPs), please list the dossier numbers and substances here: CEP / Substance name 1.2 Type of applicati

3、on (Please tick one box only)Notification (may include several changes)Minor revision (may include several changes including notifications) Major revision (may include notifications and minor changes)Renewal (notifications and minor changes may be included) Grouped revision (several dossiers affecte

4、d)Transfer of holdership 2.Names and addresses2.1Certificate holder:(N.B. for exceptional cases where the holder will not be the manufacturer please refer to 4.2)Name of the company*Address*Postcode*Town*Country*Telephone*Fax*E-mail*Name of a contact person within the company (if different from 2.2)

5、Fields marked * are mandatory2.2 Contact person authorised for communication on behalf of the holder :(if different from manufacturer please provide an authorisation letter - see Annex 1): Title* (Mrs, Mr, Dr)First name*Family name*Job title/DepartmentName of the company*Address for correspondence*P

6、ostcode*Town*Country*Telephone*Fax*E-mail*Fields marked * are mandatory2.3 Manufacturing site(s): detailed name and address of all sites involved in the manufacture of this substance (if different from the intended holder, please also refer to 4.2) All sites involved in the manufacture of the active

7、 substance from the introduction of starting material(s), including quality control / in process testing sites, intermediate manufacturers, milling, micronisation and sterilisation sites should be listed in separate boxes and their role should be specifiedRole*Name of the company *Address*Postcode*T

8、own*Country*Telephone*Fax*E-mail*GPS (WGS 84) coordinates of the site*:Latitude (S or N) and Longitude (E or W) expressed in Degrees Minutes Seconds to 1 decimal place (Alternatively it can be expressed in Degrees to at least 5 decimal places or Degrees Minutes to at least 3 decimal places) main ent

9、rance if not main entrance, specify the place:DUNS numberFields marked * are mandatoryRole*Name of the company *Address*Postcode*Town*Country*Telephone*Fax*E-mail*GPS (WGS 84) coordinates of the site*:Latitude (S or N) and Longitude (E or W) expressed in Degrees Minutes Seconds to 1 decimal place (A

10、lternatively it can be expressed in Degrees to at least 5 decimal places or Degrees Minutes to at least 3 decimal places) main entrance if not main entrance, specify the placeDUNS numberFields marked * are mandatory 3.Specific InformationTick the appropriate change(s)NotificationsImmediateAnnualImpl

11、ementation date (annual notifications)Change in the name and/or address of the certificate holder of the final substance*-Change in the name and/or address of the manufacturing site or quality control site for the final substance*-Deletion of a manufacturer of intermediate or of a manufacturing or q

12、uality control testing site for the final substance-Change in the name and/or address of a manufacturer of an intermediate used in the manufacture of the final substance*-Change or addition of a manufacturer of a starting material or intermediate used in the manufacturing process of the final substa

13、nce when the proposed manufacturer is part of the same group as the currently approved manufacturer-Change or addition of a manufacturing site/workshop for the final substance when the proposed manufacturer is part of the same group as the currently approved manufacturer*-Changes to quality control

14、testing for an intermediate or for the final substance-Introduction of a new site of micronisation*-Tightening of the specification limits for the final substance-Minor changes to a test procedure for the final substance. Editorial changes to a method description annexed to a certificate of suitabil

15、ity-Addition of a specification parameter for the final substance-Change in the composition of the immediate packaging-Change in the composition of the secondary packagingRemoval/reduction of the re-test period from the Certificate of suitability / change to more restrictive storage conditions-Chang

16、e to an approved stability protocol-Deletion of an approved change management protocol related to the final substance-Implementation of changes foreseen in an approved change management protocol that does not require further supportive data-Introduction of a new CEP to describe a starting material u

17、sed in the manufacturing process of a final substance -Introduction of a revised CEP for a starting material when the manufacturing sites mentioned on this CEP are changed-Deletion of a CEP for a starting material -Change in the name and/or address of a manufacturer of a starting material used in th

18、e manufacture of the final substance-Deletion of a manufacturer or a quality control site for a starting material used in the manufacture of the final substance-Change in the code product/reference number and/or in the brand name of the final substance or any material used in its manufacture-Changes

19、 to quality control testing for a starting material-Minor change in the manufacturing process of the final substance-Change in batch size of final substance or intermediate up to 10-fold compared to the original batch size-Change in batch size of final substance or intermediate: downscaling up to 10

20、-fold-Addition of a new in-process test and limit applied during the manufacture of the final substance-Deletion of a non significant in-process test applied during the manufacture of the final substance-Tightening of the limits of in-process tests applied during the manufacture of the final substan

21、ce-Addition of a specification parameter for a starting material/intermediate/reagent-Deletion of a non-significant specification parameter for the final substance/starting material/intermediate or deletion of a test procedure for a starting material/intermediate/reagent-Minor changes to a test proc

22、edure for a starting material/intermediate/reagent used in the manufacturing process of the final substance-Tightening of the specification limits for a starting material/ intermediate/reagent used in the manufacturing process of the final substance-Change in the specification parameters and/or limi

23、ts of the immediate packaging of the final substance-Change in the specification of the secondary packaging-Submission of a revised CEP for a starting material, when the manufacturing sites mentioned on this CEP are unchanged-* updated declarations according to the relevant annexes are to be submitt

24、edNotifications for TSE certificatesImmediateAnnualImplementation dateDeletion of a source country or deletion of a tissue used in the preparation of the final product-Change or addition of a manufacturing site for the final substance when the proposed manufacturer is part of the same group as the a

25、pproved manufacturer*-Change in the quality assurance system applied in the manufacturing site*-Minor change in the specification of the final substance-Minor change in the manufacturing process (including process parameters) of the final substance-* updated declarations according to the relevant an

26、nexes are to be submittedMinor changesChange or addition of a manufacturer of a starting material used in the manufacturing process of the final substanceChange or addition of a manufacturer of an intermediate used in the manufacturing process of the final substance*Change or addition of a manufactu

27、rer of a starting material used in the manufacturing process of a biological substanceChange or addition of a manufacturer of an intermediate used in the manufacturing process of a biological substance*Change or addition of a manufacturing site/workshop for the final substance*Change or addition of

28、a manufacturer for a biological substance*Addition of an alternative sterilisation site for the final substance*Minor changes to the manufacturing process of a biological substanceFor a “double” Certificate of suitability (for chemical purity and microbiological quality and for TSE risk), change in

29、source of a material used in the preparation of the final substance from a TSE risk material to a vegetable, synthetic, or non-TSE risk materialChange in batch size of final substance or an intermediate more than 10-fold compared to the original batch sizeChange in batch size of a biological substan

30、ceWidening of approved specification limits for the final substance to be in line with the limits of the Ph. Eur monograph/ICH/VICH guidelinesMinor changes to the manufacturing process of a biological substance, including change in batch sizeChanges to a test procedure (including replacement or addi

31、tion) for the biological substance/starting material/intermediate or changes to a biological methodExtension/addition of the re-test period of the final substance and/or change in the storage conditions for the final substanceProposed retest period (in months)Commercial packagingRecommended storage

32、conditionsMinor changes to an approved change management protocol that do not change the strategy defined in the protocolImplementation of changes foreseen in an approved change management protocol that requires further supportive dataIntroduction of a new CEP for a starting material, when the speci

33、fications of the starting material are changedSubmission of a revised CEP for a starting material, when the specifications mentioned on this CEP are changedOther minor changes (by default) Describe briefly any non-listed minor changes in this box : * updated declarations according to the relevant an

34、nexes are to be submittedMajor changesChange/addition of the manufacturer of a starting material or intermediate, when the proposed manufacturer uses a substantially different route of synthesis or manufacturing conditions, which are likely to change the qualitative and/or quantitative impurity prof

35、ile (eg. new reagents, solvents, materials are introduced in the synthesis)*Change in the manufacturing process of the final substance that regards the sterilization step(s), including changes in batch size of a sterile substanceSubstantial change to the manufacturing process/addition of an alternat

36、ive manufacturing process for a starting material, intermediate or final substance likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)Changes in the manufacturing process of a herbal substance related to geogra

37、phical source or productionWidening or deletion of approved in-process test limits, which may have a significant effect on the overall quality of the final substanceWidening of the approved specification limits for the final substanceWidening of the approved specification limits for starting materia

38、ls/ intermediates, which may have a significant effect on the overall quality of the final substanceDeletion of a specification parameter which may have a significant effect on the overall quality of the final substanceChange in the composition of immediate packaging for a sterile substanceIntroduct

39、ion of a new design space or extension of an approved design space or of a post approval change management protocol related to the final substanceIntroduction of a post approval change management protocol related to the final substanceMajor changes to an approved change management protocolDeletion o

40、f a CEP for a starting material and replacement by another source that does not have a CEPMajor changes for TSE certificatesChange/addition of a source country or tissues for TSE risk materialChange/addition of a manufacturer of a starting material or intermediate*Change/addition of a manufacturing

41、site where other TSE materials than the substance are processed*Substantial changes in the manufacturing process that are likely to affect the TSE risk* for a manufacturer of intermediate or the final substance, updated declarations according to the relevant annexes are to be submitted4.Comparative

42、table (as described in Annex 7) (mandatory for all submissions)The comparative table should highlight the differences between the approved and proposed text of module 3, together with the correct classification of each change according to the EDQM Guideline for revisions.5.Declarations5.1. Signed ho

43、lders commitments (as described in Annex 6) (for all submissions)5.2 Updated declarations (when relevant) Signed declaration of manufacture (for each manufacturing site, if relevant) in accordance with the dossier and according to GMP rules (as described in Annex 3a) (or, if the substance is not a d

44、rug substance, a suitable quality assurance system, specifying which rules/guidelines/standards are followed, as described in Annex 3b). Signed declaration of willingness to be inspected (for each manufacturing site, if relevant). This also applies for holders when different from manufacturers (as d

45、escribed in Annex 4). Signed declaration on use or non-use of materials of human or animal origin including TSE risk materials (not to be submitted in case of an application for a TSE certificate) (as described in Annex 5) Holder different from manufacturer: In exceptional cases where the holder of

46、the certificate will not be the manufacturer, please provide the following declarations: A declaration from the manufacturer to commit to inform the holder of any change made so that the dossier submitted to the EDQM can be updated without any delay by the holder (see Annex 2). Declarations of willingness to be inspected from both the holder and the manufacturer (as described in Annex 4)6.History of the productThis section is to