by Dr. Yashashwini Reddy | Oct 9, 2025
Elaboration:The development and manufacture of drug substances (Active Pharmaceutical Ingredients – API) encompass all stages from the initial synthesis or isolation of the active compound to its large-scale commercial production under Good Manufacturing Practice...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To establish a procedure for regular inspection of utilities (e.g., purified water, compressed air, HVAC system, steam, and gas supply) to ensure compliance with GMP requirements and operational efficiency. 2. Scope This procedure applies to all utility...
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...
