VICH Topic GL2 (Validation: Methodology)

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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 APPROP

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

  Validation, Methodology, Vich, Vich gl2, Validation methodology