Spring Intro 2023

28/03/2023

3.2.S.4 Control of Drug substance

• Analytical Development is a crucial element of drug substance development

• Analytical methods are used to

– Confirm the identity of the drug substance – Identify and quantify any impurities – Understand the stability profile of the drug – Identify key drug substance characteristics

• Validity of pre-clinical and clinical bio-batches rests on reliability of analytical data • Key part of the submission 3.2.S and 3.2.P – analytical methods and specification (ICH Q2 – analytical validation, Q6A and B specifications )

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3.2.S.5 Reference standards or materials

• What is a reference standard? • A well-characterised lot of DS that of known potency and purity. Used as an independent reference to compare against routine commercial lots to confirm identity, potency impurities • Include information on all reference standards – drug substance and impurities • Include characterisation data for the reference standards in this section

The Organisation for Professionals in Regulatory Affairs

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