A comparative analysis between ICH Q2(R2) and ICH Q14

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The ICH has been instrumental in establishing guidelines that ensure the quality, safety and efficacy of medicines. The main purpose of using non-binding recommendations is to harmonise pharmaceutical approaches and facilitate consistent regulatory evaluations. ICH Q2(R2) is one of these guidelines, which provides comprehensive direction on the validation of analytical procedures, which is a critical aspect of pharmaceutical development and quality control. Recently, the ICH has proposed a new guideline, ICH Q14, which aims to complement and expand on the principles established in ICH Q2(R2). For researchers responsible for developing and maintaining analytical procedures throughout the analytical procedure lifecycle, new insights into the phase-appropriate requirements are a good complement to existing guidance. The comments originating from pharmaceutical industry experts on ICH Q14 and the expectations about the well-known and established ICH Q2(R2) will be explored in this article.

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