by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Weighing & Dispensing 1. Area & Environment Weighing/dispensing area dedicated, controlled, and clearly labeled. Differential pressure maintained between adjacent areas. Environmental conditions (temperature, humidity, cleanliness)...
by Dr. Yashashwini Reddy | Sep 6, 2025
The Importance of FDA Form 483s and Warning Letters in Pharmaceuticals 1. What is FDA Form 483? FDA Form 483, “Inspectional Observations,” is issued by FDA inspectors to company management at the end of an inspection. It lists potential violations of the Food, Drug,...
by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 Various Types of Blenders and Their Purpose 1. Double Cone Blender (DCB) Purpose: Used for homogeneous mixing of dry powders and granules. Advantages: Gentle mixing, suitable for fragile materials, low shear force. Applications: Commonly used in powder mixing for...
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for an Automatic Capsule Filling Machine, typically used in pharmaceutical manufacturing for precise and efficient encapsulation. 1. Purpose To...
by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish a standardized method for the safe and efficient operation of the 20-station single rotary tablet compression machine, ensuring consistent tablet quality and compliance with Good...
