Spring Intro 2023

28/03/2023

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

For solid oral dosage forms, specifications should include content uniformity (Ph. Eur. 2.9.40). • If the tablet has a sub-division, a specification demonstrating compliance Ph. Eur. monograph for Tablets.

For liquid preparations for oral use supplied in multidose containers, a test for uniformity of mass of delivered doses from multidose containers (Ph. Eur. 2.9.27). • Dosing aid (measuring spoon, cup, etc.), the dosing accuracy is to be verified in accordance with test Ph. Eur. 2.9.27.

For modified release drug products, related to the dissolution tests, a minimum of three points should be defined on prolonged release tablets as it is defined on the “Note for Guidance on Quality of Modified Release Products” (CPMP/QWP/604/96).

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P.5.4 Batch analyses – Include batches used in clinical or bioavailability studies – Give details of batch size and manufacturing date 3.2.P Drug Product 3.2.P.5 Control of Drug Product (Continued)

P.5.5 Characterisation of impurities – If not previously provided in 3.2.S – Any impurities seen in drug product but not in drug substance

P.5.6 Justification of specification – Need to cover both the tests performed and the limits applied

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