ICH

Difference Between ICH and ISO Guidelines
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Difference Between ICH and ISO Guidelines

Elaboration   Focus   Development ICH developed through the collaboration of regulatory authorities and pharmaceutical industries. ISO developed through the technical committees.   Scope ICH concentrates on technical and scientific aspects of pharmaceutical product development and registration. ISO covers various management system, processes, and requirements.     Applicability Often mandatory for regulatory compliance in countries…

Overview of the ICH Guidelines
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Overview of the ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that brings together regulatory authorities and the pharmaceutical industry to develop and promote harmonized guidelines and standards for the development, registration, and post-approval of pharmaceutical products.   Structure of the ICH 1. Management Committee: Comprised of regulatory…