Significance of ICH Guideline
The ICH Guideline refers to standards established by the International Council for Harmonisation that ensure the quality, safety, and efficacy of pharmaceuticals. These guidelines provide a framework for various aspects of drug development, including the validation of analytical methods, stability testing, and regulatory requirements. Adhering to these guidelines helps ensure consistency and reliability in the testing of pharmaceuticals, supporting their safe use in human health. Overall, ICH guidelines play a crucial role in harmonizing global pharmaceutical standards.
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of ICH Guideline in scientific sources
The ICH Guideline encompasses international standards for harmonizing quality, safety, and efficacy in pharmaceuticals, including analytical method validation, photostability testing, and HPTLC method accuracy and precision, ensuring consistent regulatory practices.
From: World Journal of Pharmaceutical Research
(1) International Council for Harmonisation guidelines under which the developed methods were validated to ensure quality and safety.[1] (2) International Council for Harmonisation guidelines established to ensure quality, safety, and efficacy of pharmaceuticals.[2] (3) International standards that provide criteria for the validation of analytical methods, including parameters like linearity, accuracy, and precision.[3] (4) International Council for Harmonisation guidelines referred to in the validation of the UV spectrophotometric method for Lamivudine.[4] (5) International guidelines for the validation of analytical methods, which establish the standards of quality and consistency in drug analysis.[5]
From: Journal of Ayurveda and Integrative Medicine
(1) International Conference on Harmonisation guidelines that are used to validate analytical methods.[6]