GMP in Pharmaceutical Industry: Global cGMP & Regulatory Expectations

<div><!--block-->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.<br>&nbsp;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.<br>&nbsp;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.<br><br><strong>Contents: 1.</strong> GMP Regulations for Pharmaceutical Industry<strong>2.</strong> Good Laboratory Practices in Pharmaceutical Industry<strong>3.</strong> Good Microbiology Practice in Pharmaceutical Industry<strong>4.</strong> Good Aseptic Practices in Pharmaceutical Industry<strong>5.</strong> Good Clean Room Monitoring in Pharmaceutical Industry<strong>6.</strong> Good Engineering Practices in Pharmaceutical Industry<strong>7.</strong> Good Alarm Management Practices in Pharmaceutical Industry<strong>8.</strong> Good Computer Validation System Practices in Pharmaceutical Industry<strong>9.</strong> Good Distribution Practices—Supply Chain Integrity in Pharmaceutical Industry<strong>10.</strong> Good Data Management System in Pharmaceutical Industry<strong>11.</strong> Quality Agreements in Pharmaceutical Industry<strong>12.</strong> Change control Management and its Applications<strong>13.</strong> Technology Transfer of Pharmaceutical Product<strong>14.</strong> Pharmaceutical Annual Product Quality Review<strong>15.</strong> Statistical Tools for Pharmaceutical Industry<strong>16.</strong> Application of Different Quality Tools in Investigation of Non-Conformance Observations<strong>17.</strong> New Approach to the Internal Audit from Traditional to Risk based Approach<strong>18.</strong> Quality by Design (QbD) Approach in the Product Life Cycle<strong>19.</strong> Process Validation in Pharmaceutical Industry<strong>20.</strong> Cleaning Validation and Cross Contamination Approach on Risk MaPP Concept<strong>21.</strong> Pharmaceutical Water Generation and Distribution System and Regulatory Expectation<strong>22.</strong> Pharmaceutical Heating, Ventilation and Air Conditionings (HVAC) and Regulatory Expectations<strong>23.</strong> Manufacturing Execution System (MES) in Pharmaceutical Industry<strong>24.</strong> Pharmaceutical Drug Master File<strong>25.</strong> Common Technical Document in Regulatory Filing<strong>26.</strong> European Union Marketing Authorization<strong>27.</strong> Site Master File<strong>28.</strong> Standard Operating Procedure (SOP)<strong>29.</strong> Quality Manual<strong>30.</strong> Human Error Reduction: Pharma Industry Challenge<strong>31.</strong> Regulatory Inspections: Face Challenges through Proactive Measures<strong>32.</strong> Pharmaceutical GMP: Past, Present, and Future – A Review<br><br><strong>About the Author:<br><br>Trupti Patil-Dongare</strong> 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.<br>&nbsp; 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 &amp; Dossiers. Preparing, responding and committing to the regulatory bodies for deficiencies and queries. Knowledge on various national &amp; international standards.<br>&nbsp;Skilled in Quality Audits, Contract manufacturing, loan licensing sites (Sterile &amp; non-sterile) &amp; analytical testing sites.</div>