All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Abstract

Handling of Pharmaceutical Deviations: A Detailed Case Study

Author(s): DAMINI V, S. H. KUMAR*, H. V. GANGADHARAPPA AND M. P. GOWRAV
Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India

Correspondence Address:
S. H. KUMAR, Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India, Email: [email protected]


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 procedure or a documented standard. Deviations occur almost every day in the pharmaceutical industries, handling of deviations and minimising the recurrence of them has very critical considerations in the quality management system of the pharmaceutical industry. This article explains the procedure for handling of deviations by identifying the deviation, understanding its criticality, conduct root cause analysis and suggesting corrective and preventive action for it. This is explained through various case studies such as out of calibration equipment’s, facility modification, temperature excursions, out of specification during the manufacturing process, with a detailed process about the handling of deviations.

Full-Text | PDF