Spring Intro 2023

28/03/2023

3.2.P.2 Pharmaceutical development

Tablet & Capsule dissolution

Critical Quality Attribute for most solid dosage forms Addressed by ICH Q6A on Drug Product Specifications (Decision Tree #7) Considered to have 2 main functions: ● As a QC test to demonstrate quality and batch-to-batch uniformity ● As a surrogate to in-vivo absorption and product performance Measured by a pharmacopoeial dissolution test, or other appropriately justified model Justification of test and specification in accordance with decision trees

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3.2.P.2 Pharmaceutical development Sterile Dosage forms

Choice of sterilisation must be thoroughly demonstrated – use decision tree on sterility

“Guideline on the Sterilisation of the medicinal product, Active substance, excipient and primary container” – March 2019

https://www.ema.europa.eu/en/documents/scientific guideline/guideline-sterilisation-medicinal-product-active substance-excipient-primary-container_en.pdf

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