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Recent Posts
Q5: Biotechnological Products
Definition:Biotechnological products are therapeutic substances that are produced using living organisms, cells, or biological...
Q3: Impurities
Elaboration:Impurities are unwanted chemicals that remain with the active pharmaceutical ingredient (API) or develop during...
Q2: Analytical Validation
๐งช ICH Q2: Analytical Validation ๐น Full Title: ICH Q2(R2) โ Validation of Analytical Procedures ๐น Objective: To provide guidance...
Q1: Stability Testing
๐ ICH Q1: Stability Testing ๐น Purpose The ICH Q1 series provides guidance on how to design stability studies to ensure that drug...
Quality Guidelines
๐งญ Quality Guidelines โ Overview Quality Guidelines are internationally harmonized standards developed mainly by the...
What are the Different Formats of Pharmaceutical Audits?
Formats of Pharmaceutical Audits On-Site Audit (Physical Audit) Conducted at the manufacturing site, laboratory, warehouse, or...