Deviation
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
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
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More
Inadequate Investigations: A Common Observation by the FDA
During cGMP inspections, one of the most commonly cited observations by the FDA is the inadequate investigation into deviations. Pharmaceutical companies must address this issue to maintain compliance and ensure patient safety. Here are some key points to keep in mind regarding deviation investigations in the pharmaceutical industry: Observation Highlight ... 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