🔑 1. Follow Written Procedures (SOPs) 📖 Explanation Every activity must be performed according to an approved SOP. SOPs ensure consistency, reproducibility, and compliance. 🧪 Real Example Case: Granulation process in solid dosage section 👉 Audit Finding: Process deviation👉 Impact: Read More …
Tag: guideline
Dissolution, Disintegration, Hardness & Friability Testers in Pharmaceutical QC
In pharmaceutical quality control (QC), solid oral dosage forms such as tablets and capsules must consistently meet predefined performance and mechanical integrity standards. Four essential instruments—dissolution tester, disintegration tester, hardness tester, and friability tester—play a critical role in ensuring compliance Read More …
EMA Releases New Guideline on the Chemistry of Active Substances (2026)
🚨 EMA Releases New Guideline on the Chemistry of Active Substances (2026): What Pharma Professionals Must Know ⚕️ European Medicines AgencyOFFICIAL RELEASE 🔥 NEW GUIDELINE 2026 Chemistry of Active Substances ICH Q11 alignment • Quality by Design (QbD) • Advanced Read More …
Mastering FDA Inspections: The Power of Regulatory Storyboarding
A Complete Guide for Pharmaceutical Professionals in Bangladesh Introduction: Why Companies Fail FDA Inspections In today’s highly regulated pharmaceutical environment, passing an inspection by the U.S. Food and Drug Administration is not just about having data—it’s about presenting that data Read More …