1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka State, India-576104
2Department of Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka State, India-576104
*First Author E-mail: krissrcm@gmail.com
**Corresponding Author E-mail: girish.pai@manipal.edu
Online published on 5 May, 2014.
Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do occur knowingly or unknowingly. A deviation needs to be addressed and investigated with proper corrective actions and preventive actions (CAPA) to avoid recurrence. This is a regulatory requirement too. Deviation can result from malfunctioning of equipment, non-conforming materials and human errors as well. In this article, we have tried to outline various types, with few examples and a brief handling procedure for handling deviations efficiently.
Process deviations, CAPA and Regulatory requirements
