Transcription of Q 2 (R1) Validation of Analytical Procedures: Text and ...
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Q 2 (R1) Validation of Analytical Procedures: Text and ...
European Medicines Agency June 1995. CPMP/ICH/381/95. ICH Topic Q 2 (R1). Validation of Analytical Procedures: Text and Methodology Step 5. NOTE FOR GUIDANCE ON Validation . OF Analytical PROCEDURES: TEXT AND METHODOLOGY. (CPMP/ICH/381/95). APPROVAL BY CPMP November 1994. DATE FOR COMING INTO OPERATION June 1995. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK. Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40. E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged PART I: Validation OF Analytical PRROCEDURES: DEFINITIONS AND METHODOLOGY.
The objective of validation of an analytical procedure is to demonstrate that it is suitable for ... normally achieved by comparison of a property of the sample (e.g., spectrum, chromatographic behavior, chemical reactivity, etc) to that of a reference standard. ... usually applied to standardization of methodology). 5. Detection Limit
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