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Common Technical Document (CTD)

31 December, 2024 admin 0 Comments

Common Technical Document (CTD) In the pharmaceutical world, the Common Technical Document (CTD) is a cornerstone of regulatory submissions. Whether it's for new drug approval, generic drug application, or other pharmaceutical licensing activities, the CTD…

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Batch Manufacturing Records

15 December, 2024 admin 0 Comments

Batch Manufacturing Records Introduction to Batch Manufacturing Records (BMR) Batch Manufacturing Records (BMR) are the backbone of pharmaceutical manufacturing. These documents capture every detail of the production process, ensuring consistency, traceability, and compliance with regulatory…

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Dissolution Testing in Pharmaceuticals (USP <711>)

17 November, 2024 admin 0 Comments

What is Dissolution Testing? Dissolution testing measures how quickly and completely a drug dissolves in a particular solvent. The United States Pharmacopeia (USP) standard for dissolution testing, known as USP <711>, provides guidelines to ensure…

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