CAPA
CAPA Management in FDA Regulated Industry
A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 ... Read More
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
SOP for CAPA (Corrective and Preventive Action) Handling Procedure
1.0 PURPOSE To lay down a procedure to be followed for administration of corrective and Preventive actions (CAPA) including tracking and reporting of the status of CAPA. 2.0 SCOPE 2.1 This procedure is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the ... 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
CAPA Process Steps in Pharmaceutical Industry
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources ... 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