欧洲药典4.5执行.pptVIP

欧洲药品质量指导委员会(EDQM)欧洲药典专论适应性认证;Supplement 4.5 of the European Pharmacopoeia describing a number of revised monographs will be implemented 1 July 2003. It is your responsibility as holder of a certificate of suitability to update specifications and test procedures for concerned pharmaceutical substances to implement the new version 07/2003 or any corrected text of the monograph in due time.;You hold a certificate for a substance for which a technically revised monograph has been published (section ‘REVISED TEXTS’, see list enclosed), you should proceed as follows:;Amendments to the monograph (eg. Preparation of a reference solution, deletion of an identification test,…) that do not require submission on your part of additional documents to complete the Certification file: Substances concerned by such amendments are annotated in the attached list as ‘1’. A reply to this letter is not necessary.;Amendments to the monograph that, as laid down in Resolution AP-CSP (99) 4, require updating of the Certification file to demonstrate whether the substance complies with the new requirements of the monograph; the extent of information to be provided depends on the actual changes/modifications in the section ‘Tests’: Updated substance specifications referring to the revised monograph and certificates of batch analyses of 1 or 2 batches based on new instructions may suffice which is annotated in the attached list as ‘2’.;Where further supporting documentation will be necessary to cover any other impurities not stated in the transparency list this is annotated in the attached list as ‘3’. In this case, the documents requested as mentioned under ‘2’ should also be provided and completed with chromatograms, cross-validation with in-house methods, comparison of impurity profile with the transparency list, …;If the requested information has already been presented this should be indicated in your reply.;In the cases ‘2’ and ‘3’ you are expected to reply to this letter and provide the su