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ICH HARMONISED TRIPARTITE GUIDELINE
www.ich.orgGOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH
ICH HARMONISED GUIDELINE
www.ich.org1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for