Abstract

A REVIEW ARTICLE ON HANDLING OF PHARMACEUTICAL DEVIATION: A DETAILED CASE STUDY

Umesh Panchal*, Ganesh S. Pawar, Rutuja R. Sumbe, Dr. Ganesh R. Godge

ABSTRACT

Deviations are the differences which are measured between the expected or normal values and the observed values for a product or process condition from a technique or a recorded standard. Deviations occur almost every day in the pharmaceutical industries, handling of deviations and limiting the recurrence of them has very essential considerations in the quality management system of the pharmaceutical industry. This article discusses the approach for handling of deviations by recognising the deviation, analysing its criticality, conduct root cause analysis and providing remedial and preventive action for it. This is explained through several case studies such as out of calibration equipment’s, facility alteration, temperature excursions, out of specification during the manufacturing process, with a detailed process about the treatment of deviations.

Keywords: Deviations, Root cause, Criticality, Corrective and Preventive Action.