In this lecture, we discuss SUPAC Guidelines (Scale-Up and Post-Approval Changes) from Industrial Pharmacy (B Pharm 7th Semester) in simple Malayalam.
📌 Topics Covered:
Introduction to SUPAC Guidelines
Importance in pharmaceutical industry
Types of SUPAC: IR, MR, SS
Level of changes:
Level 1 (Minor)
Level 2 (Moderate)
Level 3 (Major)
Requirements for documentation & filing (Annual report, CBE, PAS)
Applications in formulation scale-up & manufacturing changes
Advantages, disadvantages, and limitations
👉 Very useful for B Pharm, GPAT, Pharmacist exams, and industry job preparation.
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