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 8400Fax: (+44-171) 418 8447E_Mail: 1998Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA isacknowledgedCVMP/ vich /591/98-FINALLond on, 10 December1998VICH Topic GL2(Validation: Methodology) Step 7 Consensus GuidelineGUIDELINE ON VALIDATION OFANALYTICAL PROCEDURES:METHODOLOGYTRANSMISSION TO CVMPDecember 1997TRANSMISSION TO INTERESTED PARTIESJanuary 1998COMMENTS REQUESTED BEFOREApril 1998FINAL APPROVAL BY CVMPDecember 1998DATE FOR COMING INTO OPERATION BYOctober 1999FOR IMPLEMENTATION AT STEP 7 - 22/10/1998Page 1 of 10EMEA 1998VICH GL2 (VALIDATIONMETHODOLOGY)October 1998For implementation Step 7VVVVALIDATION OF AAAANALYTICALPPPPROCEDURES::::MMMMETHODO LOGYRecommended 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 - 22/10/1998Page 2 of 10EMEA 1998VALIDATION OF ANALYTICAL PROCEDURES:METHODOLOGYTABLE OF Assay and Impurity Test(s).
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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