Overview

This handbook has been written for the students of pharmacy and pharmaceutical industry. It gives pocket guide of good manufacturing practices in pharmaceutical industry. The purpose of this handbook is to provide easily accessible knowledge about the pharmaceutical industry and to assist individuals to know about pharmaceutical world.This handbook has also incorporated the current trends and expectations of the evolving pharmaceutical industry and regulatory oversight. In current pharmaceutical world we need a fast and reliable source of techniques to implement the system and resolve problem. This handbook gives pathway for us to take right decision. Nothing comes in a one box for us. Changes happen with or without us. The higher we go in the organization, the more complex our challenges become. This book gives overall view of quality management system We hope this handbook can contribute to assemble lots of related materials and package them in one place for easy reference and access. I encourage you to read, enjoy, study, and learn from this book, and go forth and empower your teams to lead you and your organization to world class results

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9789388305143

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Trupti Patil-Dongare has over 14 years of experience in pharmaceutical industry in quality assurance, quality Control, regulatory compliance and production. I am Master in Industrial Pharmacy from Osmania University, Hyderabad, India and Advance Diploma in Pharmaceutical Quality Assurance Management from Institute of Pharmaceutical Education and Research Pune, Maharashtra, India. Versatile knowledge on all key functions of Non sterile API, Sterile API and formulation QA. Ample exposure to Regulatory affairs for filling the ANDAs, DMFs & Dossiers. Preparing, responding and committing to the regulatory bodies for deficiencies and queries. Knowledge on various national & international standards. Skilled in Quality Audits, Contract manufacturing, loan licensing sites (Sterile & non-sterile) & analytical testing sites.

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