Deviation
The Power of Root Cause Analysis | A Lifeline for the Pharmaceutical Industry
The pharmaceutical industry operates under a microscope, with every step demanding unwavering adherence to stringent quality standards. A single mistake can have devastating consequences, from product recalls to compromised patient safety. This is where “Root Cause Analysis (RCA)” takes center stage, becoming a vital tool for preventing future failures and ... Read More
Root Cause Analysis (RCA) in Pharma Industry
Root cause analysis (RCA) is a structured method for identifying the main cause of a problem and implementing changes to the system. RCA tools and techniques that can be used in CAPA The 5 Whys: A simple technique that involves asking “why” five times to get to the root cause ... Read More
Corrective Action and Preventive Action (CAPA)
CAPA is a fundamental quality management tool for pharmaceutical industry. Implementing an effective corrective or preventive action capable of satisfying regulatory authorities also. Corrective Action The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation. Preventive Action The action was taken to eliminate the ... Read More
Deviation in Pharmaceutical Industry
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. In this article we briefly discuss on types of deviation and management of deviation. Deviation Terminology When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works ... Read More