{"product_id":"modern-aspects-of-pharmaceutical-quality-assurance-developing-proposing-application-models-sops-practical-audit-systems-for-pharma-industry","title":"Modern Aspects of Pharmaceutical Quality Assurance: Developing \u0026 Proposing Application models, SOPs, practical audit systems for Pharma Industry","description":"\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"0993745598\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"7y9w7h-rgk3d4-2xixgp-6jetc1\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv aria-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"3xu427-hdulpm-xey1d9-kajk0v\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"1975136373\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" aria-expanded=\"false\"\u003e\n\u003cp\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cbr\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThis book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cbr\u003e\u003cbr\u003eThe chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System\u003c\/span\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003e Table of contents (13 chapters)\u003c\/strong\u003e\u003cbr\u003eFront Matter\u003cbr\u003ePages i-viii\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003eIntroduction: Quality Assurance from Perspective of Pharmaceutical Industry\u003cbr\u003eMinal Ghante, Shrikant Dargude, Arpana Patil, Vidhya Bhusari\u003cbr\u003ePages 1-7\u003cbr\u003eSix Sigma Model in Pharma Industry: Part – I\u003cbr\u003eMinal Ghante, Shrikant Dargude, Vishal Zambre, Sanjay Sawant\u003cbr\u003ePages 9-19\u003cbr\u003eSix-Sigma Model in Pharma Industry: Part – II\u003cbr\u003eMinal Ghante, Shrikant Dargude, Vishal Zambre, Sanjay Sawant\u003cbr\u003ePages 21-50\u003cbr\u003eDeveloping a Practical Audit System for a Pharmaceutical Industry Based on Six System Inspection Model\u003cbr\u003eAishwarya Pawar, Manohar Potdar, Gaurav Malbhage, Vidhya Bhusari, Minal Ghante, Vandana Nikam\u003cbr\u003ePages 51-72\u003cbr\u003eCompliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries\u003cbr\u003eSimran Shaikh, Manohar Potdar, Prem Goel, Akansha Lonkar, Minal Ghante\u003cbr\u003ePages 73-91\u003cbr\u003eDeveloping an Application Model for Planning, Controlling, Improving, and Assuring Quality for Pharmaceutical Industry: Covering Quality Planning and Quality Control\u003cbr\u003eSwati Bargal, Manohar Potdar, Rinku Dey, Vidhya Bhusari\u003cbr\u003ePages 93-166\u003cbr\u003eDeveloping an Application Model for Improving Quality of Pharmaceutical Manufacturing Based on the Quality Principles – Covering Quality Improvement and Quality Assurance Audit\u003cbr\u003eVidhya Bhusari, Manohar Potdar, Raskar Madhuri, Akansha Lonkar\u003cbr\u003ePages 167-227\u003cbr\u003eDeveloping a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Tablets and Capsules Manufacturing Department\u003cbr\u003eVidhya Bhusari, Manohar Potdar, Pratiksha Nandalwar, Prayas Warbhe, Minal Ghante\u003cbr\u003ePages 229-326\u003cbr\u003eDeveloping a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Liquid Oral and Ointment Department\u003cbr\u003eVidhya Bhusari, Manohar Potdar, Pragati Sawkar, Monika Jadhav, Minal Ghante\u003cbr\u003ePages 327-362\u003cbr\u003eDeveloping a Simplified Model Standard Operating Procedure to Implement Quality Metrics for Pharmaceutical Manufacturing System\u003cbr\u003eManohar Potdar, Madhuri Hivrale, Neha Bhavare, Rohan Thosar, Supriya Jagtap\u003cbr\u003ePages 363-380\u003cbr\u003eDocumentation and Data Integrity in Pharmaceutical Industry\u003cbr\u003ePreeti Kulkarni, Charmy Kothari\u003cbr\u003ePages 381-403\u003cbr\u003eQuality Risk Management\u003cbr\u003eAbhay Walvekar, Akash Ambhore, Rahul Bankar, Shital Godse\u003cbr\u003ePages 405-443\u003cbr\u003eDeviation, Change, Control, and CAPA\u003cbr\u003eAbhay Walvekar, Rahul Bankar, Sayaji Patil, Priti Kalghuge, Vasundhara Sawant\u003cbr\u003ePages 445-523\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cb\u003eBOOKREAD™ 5-STEP SATISFACTION GUARANTEE\u003c\/b\u003e\u003c\/strong\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e1. No Risk, 30-Day Money-Back Guarantee. \u003cbr\u003e2. instant download. No surprises or hidden fees.\u003cbr\u003e3. Safe Payments via Credit\/Debit Card or PayPal® \u003cbr\u003e4. McAfee™ and SSL secured shopping cart.\u003cbr\u003e5. lifetime customer support.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"My Store","offers":[{"title":"PDF","offer_id":56778118005067,"sku":null,"price":29.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1031\/1204\/8971\/files\/61sN-Ym_mbL._SL1246.jpg?v=1773316368","url":"https:\/\/bookread.io\/products\/modern-aspects-of-pharmaceutical-quality-assurance-developing-proposing-application-models-sops-practical-audit-systems-for-pharma-industry","provider":"bookread","version":"1.0","type":"link"}