Deviation

Necessity of Thorough Deviation and Complaint Investigations

Necessity of Thorough Deviation and Complaint Investigations

One of the most frequently cited issues during FDA inspections pertains to the failure to conduct thorough investigations regarding unexplained discrepancies. Once an investigation is conducted and findings are documented, 21 CFR 211.192 emphasizes the necessity of implementing follow-up actions to prevent the recurrence of discrepancies or product failures. Companies ... Read More
Deviation Management and Root Cause Analysis

Deviation Management and Root Cause Analysis

In the life sciences industry, maintaining the highest quality standards is non-negotiable. Deviations, or departures from established procedures, are inevitable, but how we manage them makes all the difference. Here’s why Deviation Management and Root Cause Analysis (RCA) are pivotal: Ensuring Compliance and Safety: Systematic Investigation: Preventative Measures: Continuous Improvement: ... Read More
The Power of Root Cause Analysis | A Lifeline for the Pharmaceutical Industry

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) 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)

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

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