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 DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11 Current Step 4 version dated 1 May 2012 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. Q11 Document History Code History Date Q11 Approval by the Steering Committee under Step 2 and release for public consultation.
scientific knowledge are used more extensively to identify and understand process parameters and unit operations that impact critical quality attributes (CQAs) and develop appropriate control strategies applicable over the lifecycle of the drug substance which may include the establishment of design space(s).
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