Good Laboratory Practices and Compliance Monitoring

<div><!--block-->This handbook is fully updated to the current regulatory requirement in the pharmaceutical laboratory world. Purpose of book is to assist individual on Gx Prequirement, good manufacturing practices, good laboratory practices, performance monitoring and root cause analysis and quality triangles<br>&nbsp; The purpose of this hand book is to provide easily accessible knowledge about the good laboratory practices. 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 one box for us. Changes happen with or without us. The higher we go in the organization, the more complex ore challenges become .This book gives overall view of quality laboratory system. <br>&nbsp;We hope this handbook can contributes to assemble lots of related materials and package them in one place for easy reference and access.<br>I encourage you to read, enjoy, study and learn from this book and go forth and empower you/ your teams to lead you and your organization to world class results.<br><strong>Contents:<br>1.</strong> Overview of Good Laboratory Practices in Pharmaceutical Industry<strong>2.</strong> Overview of Good Microbiology Practices in Pharmaceutical Industry<strong>3.</strong> Quality Assurance Management in GLP Environment<strong>4.</strong> Laboratory Quality Manual<strong>5.</strong>&nbsp; Laboratory Quality Policy<strong>6.</strong> Laboratory Site Master Files<strong>7.</strong>&nbsp; Validation Master Plan<strong>8.</strong> Laboratory Computer-Software Validation and Qualification<strong>9.</strong> Control of Spreadsheets in GLP<strong>10.</strong> Analytical Instrument and Equipment Qualification<strong>11.</strong> Electronic and Paper-Based Data Management in GLP<strong>12.</strong> Laboratory Training and Qualification Management Program<strong>13.</strong> Reviewer Qualification Management<strong>14.</strong> Label Management in GLP Environment<strong>15.</strong> Glassware Management in GLP<strong>16.</strong> GLP Column Management<strong>17.</strong> GLP Standard Operating Procedure (SOP) Management<strong>18.</strong> GLP Specification Management<strong>19.</strong> GLP Certificate of Analysis (COA) Management<strong>20.</strong> Analytical Rounding of Results<strong>21.</strong> Handling of Residual Solvent<strong>22.</strong> Reserve Sample Management<strong>23.</strong> Pharmaceutical Product Stability Management<strong>24.</strong> Good Chromatographic Integration Practice in GLP<strong>25.</strong> Management of unknown and Extraneous Peaks in Chromatographic Tests<strong>26.</strong> Quality Agreements in Laboratory<strong>27.</strong> Sampling and Testing in Laboratory Management<strong>28.</strong> Laboratory Standard Management<strong><em>29.</em></strong> Analytical Reagent, Indicators and Volumetric Solution Management<strong>30.</strong> Statistical Tools for Pharmaceutical Industry<strong>31.</strong> Failure Investigation: To Prevent Reoccurrence<strong>32.</strong> Laboratory Failure Investigation Management Report Writing<strong>33.</strong> Deviation Management in Good Laboratory Practices<strong>34.</strong> Handling of Out of Trend (OOT) Result in Laboratory Management<strong>35.</strong> Handling of out of Specification Laboratory Results<strong><em>36.</em></strong> Pharmaceutical Change Control Management<strong>37.</strong> Data Integrity in Pharmaceutical Quality Control Laboratories<strong>38.</strong> Alarm Management in Good Laboratory Practices<strong>39.</strong> Handling of Objectionable Organisms – The Regulatory Perspective<strong>40.</strong> Quality by Design (QBD) Approach in the Product Life Cycle<strong>41.</strong> Validation Master Plan (Vmp)<strong>42.</strong> Audit in Laboratory Management<strong>43.</strong> Laboratory Environment Condition and Monitoring<strong>44.</strong> Laboratory Quality Standards Management<strong>45.</strong> Laboratory Instrument Calibration Program<strong>46.</strong> Laboratory Safety Management Program<strong>47.</strong> Roll Back Good Analytical Practices<strong>48.</strong> Laboratory Entry-Exit Procedure<br><strong>About the Author:<br>Trupti Patil-Dongare</strong> has over 16 years of experience in pharmaceutical industry. Trupti has completed Doctor of Philosophy in Pharmacy, Master's in industrial pharmacy, Advance Diploma in Quality Assurance and IRCA approved ISO 9001:2015 Lead Auditor.<br>&nbsp;Versatile knowledge on all key pharmaceutical function, provides technical and regulatory consulting to the pharmaceutical industry for the manufacturers of dosage forms, bulk drugs and clinical research labs. The areas of technical and consulting include validation, regulatory submissions, quality systems, facility audits, product specifications, process upgrades, product development, BA/BE clinical research and batch certification for clients. Facility design, infrastructure development and improvement for manufacturing plants for APIs, oral solids, topicals, injectables and ophthalmics for regular, oncologic and beta lactam type products in US, Europe and India with respective to quality and regulatory compliance.</div>