Spring Intro 2023

28/03/2023

3.2.P Drug Product 3.2.P.2 Pharmaceutical development

P.2.4 Container closure system. • Suitability for storage, transportation and use.

P.2.5 Microbiological attributes. ● Need for microbiological testing. ●

Effectiveness of preservative systems.

P.2.6 Compatibility ●

With reconstitution diluents, infusion fluids, dosage devices.

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3.2.P Drug Product 3.2.P.3 Manufacture

P.3.1 Name and address of manufacturer(s) P.3.2 Batch formula Include overages and reference to quality standards P.3.3 Manufacturing process Flow diagram, narrative description of process, re-processing steps, in-process controls P.3.4 Control of critical steps and intermediates P.3.5 Process validation and evaluation

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