by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Process Validation 1. General Requirements Validation Master Plan (VMP) available, approved, and up to date. Validation activities aligned with regulatory guidelines (USFDA, EMA, WHO, ICH Q8–Q10). Validation performed for all critical processes...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 EMA vs FDA Expectations on Process Validation Definition:Process Validation (PV) is the collection and evaluation of data, from process design to commercial production, to establish scientific evidence that a process is capable of consistently delivering quality...
by Dr. Yashashwini Reddy | Sep 10, 2025
⚖️ Analytical Balance Drift 🔎 What is Drift? Drift refers to the gradual change in the displayed weight reading of an analytical balance over time without any actual change in the sample’s mass. It is typically observed when the balance reading keeps increasing or...
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 | Aug 29, 2025
1. Purpose To lay down the procedure for proper handling, operation, cleaning, and maintenance of microscopes to ensure accurate and reliable observations. 2. Scope This SOP is applicable to all microscopes (compound, stereo, digital, or phase-contrast) used in the...
