Transcription of VICH Topic GL2 (Validation: Methodology)
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VICH Topic GL2 (Validation: Methodology)
The European Agency for the Evaluation of Medicinal ProductsVeterinary Medicines Evaluation Unit7 Westferry Circus, Canary Wharf, London E14 4HB, UKSwitchboard: (+44-171) 418 8400 Fax: (+44-171) 418 8447E_Mail: 1998 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA isacknowledgedCVMP/ vich /591/98-FINALL ondon, 10 December1998 vich Topic GL2(Validation: Methodology) Step 7 Consensus GuidelineGUIDELINE ON VALIDATION OFANALYTICAL PROCEDURES:METHODOLOGYTRANSMISSION TO CVMPD ecember 1997 TRANSMISSION TO INTERESTED PARTIESJ anuary 1998 COMMENTS REQUESTED BEFOREA pril 1998 FINAL APPROVAL BY CVMPD ecember 1998 DATE FOR COMING INTO OPERATION BYOctober 1999 FOR IMPLEMENTATION AT STEP 7 - 22/10/1998 Page 1 of 10 EMEA 1998 vich GL2 (VALIDATIONMETHODOLOGY)October 1998 For implementation Step 7 VVVVALIDATION OF AAAANALYTICALPPPPROCEDURES::::MMMMETHODO LOGYR ecommended for Implementationat Step 7 of the vich Processon 22 October 1998by the vich Steering CommitteeTHISGUIDELINE HAS BEEN DEVELOPED BY THE APPROPRIATEVICH EXPERTWORKINGGROUP ONTHE BASIS OF THEICHGUIDELINES ON THE SAME SUBJECT AND HAS BEEN SUBJECT TOCONSULTATION BY THE PARTIES,IN ACCORDANCE W ITH THEVICH THEPROCESS THE FINAL DRAFT IS RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OF THEEUROPEANUNION,JAPAN IMPLEMENTATION AT STEP 7 - 22/10/1998 Page 2 of 10 EMEA 1998 VALIDATION OF ANALYTICAL PROCEDURES:METHODOLOGYTABLE OF Assay and Impurity Test
FOR IMPLEMENTATION AT STEP 7 - 22/10/1998 Page 1 of 10 EMEA 1998 VICH GL2 (VALIDATION METHODOLOGY) October 1998 For implementation Step 7 V A P M Recommended for Implementation
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