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Deviation handling plays a key role in assuring quality in Pharmaceutical products and by contributing to continuous improvement. Various Guidelines like WHO, ICH, EC GMP, SCHEDULE M mentions that deviation management is the regulatory requirement and be systematically handled for maintaining quality of pharmaceutical products .It is the important process of Quality Management System. Deviation is handled through a systematic process and a step wise explanation regarding procedure for Handling of Deviation is given as flow chart in the book. Important documents related to deviation like SOP, Deviation report, Log book are given in form of formats. To correct the deviation, finding the root cause is of prime importance and for that detailed Root Cause Analysis Process is explained. Change Control is an important process which handles changes as part of correction. Implementation of Corrective Action and Preventive Action(CAPA) is the outcome of deviation and plays a pivotal roll in correcting and avoiding future deviations. Book covers both change control process as well as CAPA in detail with necessary documents. Book also covers case studies for easy understanding of process.
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The author is PhD in Pharmaceutical Sciences. She is working as Professor and Head in Parul Institute of Pharmacy, Parul University, Vadodara, Gujarat, India. She has more than 15 years of experience of QA document preparation and teaching various subjects of Quality Assurance at post graduate level. She received various grants, prices & awards.
