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David Elder (JPAG member and consultant)

 

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ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

15 December 2013 | By

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…

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ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

20 August 2013 | By

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…