by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Data Falsification in the Pharmaceutical Industry Definition:Data falsification is the intentional alteration, manipulation, or fabrication of data in order to misrepresent results and meet regulatory, quality, or business expectations. It is one of the most serious...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Computerized System Validation (CSV) in Pharmaceuticals Definition:Computerized System Validation (CSV) is a documented process of ensuring that computerized systems used in GxP (Good Practice) environments consistently function as intended and comply with...
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 11, 2025
📌 Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Definition:cGMP (Current Good Manufacturing Practices) are the regulations enforced by regulatory authorities (like US FDA, EMA, WHO, MHRA, CDSCO, etc.) to ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Change Control in Pharmaceuticals Definition:Change Control is a systematic approach to managing all changes made to processes, equipment, systems, or documents in the pharmaceutical industry to ensure compliance with Good Manufacturing Practices (GMP), product...
