Transcription of ICH HARMONISED TRIPARTITE GUIDELINE
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ICH HARMONISED TRIPARTITE GUIDELINE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED TRIPARTITE GUIDELINE . GOOD MANUFACTURING PRACTICE GUIDE FOR. ACTIVE pharmaceutical ingredients . Q7. Current Step 4 version dated 10 November 2000. This GUIDELINE has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
GOOD 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
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Pharmaceutical, PHARMACEUTICAL INGREDIENTS, FINISHED PHARMACEUTICAL PRODUCTS, Pharmaceutical ingredients and, ACTIVE PHARMACEUTICAL INGREDIENTS (API) SURROGATE, ACTIVE PHARMACEUTICAL INGREDIENTS (API) SURROGATE CONTAINMENT, ACTIVE PHARMACEUTICAL INGREDIENTS, Stability testing of active pharmaceutical, Stability Testing of Pharmaceutical Products