Q13: Continuous Manufacturing

Q13: Continuous Manufacturing

Continuous Manufacturing (CM) is an advanced pharmaceutical production approach where input materials are continuously fed into the system and the processed output (finished product) is continuously removed. Unlike traditional batch manufacturing, which occurs in...
Q1: Stability Testing

Q1: Stability Testing

📘 ICH Q1: Stability Testing 🔹 Purpose The ICH Q1 series provides guidance on how to design stability studies to ensure that drug substances and drug products maintain their quality, safety, and efficacy throughout their shelf life under various environmental...
Quality Guidelines

Quality Guidelines

🧭 Quality Guidelines – Overview Quality Guidelines are internationally harmonized standards developed mainly by the International Council for Harmonisation (ICH) and other regulatory authorities (like FDA, EMA, WHO, CDSCO).They help ensure that pharmaceutical products...

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