CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report: Analytical Procedure Development

Paul Mason, Ph.D., Senior Director at Lachman Consultant Services, Inc., offers analysis and commentary on the draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures.

In this informative article, Paul outlines how draft ICH Q14 serves as broad guidance covering the development of analytical procedures based upon ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management Principles. Paul also notes linkage to ICH Q14 where there is reference to how the results of analytical method development will aid in designing the validation study and why the revised ICH Q2(R2) and new ICH Q14 guidance will hopefully encourage companies to enhance their analytical test procedures and use modern technology rather than outdated, inefficient test procedures.

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