Spring Intro 2023

28/03/2023

3.2.P Drug Product 3.2.P.4 Control of excipients

Excipients described in the European Pharmacopoeia (Ph. Eur.), must comply with the Ph. Eur. monograph ● In general, Ph. Eur. methods should be used for testing, the use of non-Ph. Eur. compendial methods must be justified ● Non-compendial methods must be described for all excipients, e.g., inks, silicon dioxide, dimethicone ● An identity test must be more than organoleptic. All non-compendial methods used to test excipients should be ICH validated. It is insufficient to claim methods are “non-product specific” to avoid validation ● Requirement includes Identification by Thin layer chromatography (TLC) and other non product specific tests ● Requirement covers all excipients, including flavours, inks, etc. Must justify the specifications of non-compendial excipients, including gelatin capsules, colorants and flavours

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3.2.P Drug Product 3.2.P.5 Control of Drug Product

P.5.1 Specifications • Provide specifications for both release and shelf life

P.5.2 Analytical procedures • Copies of pharmacopoeial methods not required • Don’t include Issue or Edition numbers when referring to pharmacopoeial methods

P.5.3 Validation of analytical procedures • Only for non pharmacopoeial methods

The Organisation for Professionals in Regulatory Affairs

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