Spring Intro 2023

03/03/2023

Common Deficiencies – 3.2.S.4

• Control of drug substance (Specification & justification, Analytical Procedures & Validation, Batch analysis)

• Active substance specification - limits for impurities do not take into consideration the qualification and identification thresholds set out in the European Pharmacopoeia monograph on Substances for Pharmaceutical Use / ICH Q3 • Missing tests and limits • Impurity specifications not controlled to 2 decimal places, e.g. 0.10% • Catalysts, heavy metals, solvents and particle size

03/03/2023

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• Control of drug substance (Specification & justification, Analytical Procedures & Validation, Batch analysis) • Specifications for impurities/metal catalysts/solvents etc. may be required. The Q&A published by QWP and available on the EMA website should be consulted for advice. • Only theoretical ? – No control • Potential? – Control (skip test possible – if present below 30% of limit) • Present - Control Common Deficiencies – 3.2.S.4 (ctd.)

03/03/2023

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