Spring Intro 2023

03/03/2023

• Control of drug substance (Specification & justification, Analytical Procedures & Validation, Batch analysis) • Incomplete method validation • USP methods • In-House methods • Forced degradation studies not submitted (stability indicating nature of methods) • Batch analysis results stating ‘complies’ instead of individual values Common Deficiencies – 3.2.S.4 (ctd.)

03/03/2023

29

29

Common Deficiencies – 3.2.S.6

• Reference standards

• No justification of an in-house standard where a pharmacopoeial reference standard is available • Standard characterised against a USP pharmacopoeial standard rather than an equivalent Ph. Eur. one

03/03/2023

30

30

15