LEADER 04686nam 22005535 450 001 9910842488703321 005 20240312121825.0 010 $a981-9992-71-0 024 7 $a10.1007/978-981-99-9271-3 035 $a(MiAaPQ)EBC31209128 035 $a(Au-PeEL)EBL31209128 035 $a(DE-He213)978-981-99-9271-3 035 $a(EXLCZ)9930864446100041 100 $a20240311d2024 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aModern Aspects of Pharmaceutical Quality Assurance$b[electronic resource] $eDeveloping & Proposing Application models, SOPs, practical audit systems for Pharma Industry /$fedited by Minal Ghante, Manohar Potdar, Vidhya Bhusari 205 $a1st ed. 2024. 210 1$aSingapore :$cSpringer Nature Singapore :$cImprint: Springer,$d2024. 215 $a1 online resource (525 pages) 311 $a981-9992-70-2 327 $aChater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry -- Chapter 2 Six-sigma Model in Pharma Industry (Part-I) -- Chapter 3. Six-sigma Model in Pharma Industry (Part-II) -- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model -- Chapter 5 -- Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries -- Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control -- Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit -- Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department -- Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department -- Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System -- Chapter 11 Documentation and data integrity in Pharmaceutical Industry -- Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA. 330 $aThe 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. This 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. The 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. 606 $aPharmaceutical chemistry 606 $aIndustrial policy 606 $aDrug delivery systems 606 $aPharmaceutics 606 $aRegulation and Industrial Policy 606 $aDrug Delivery 615 0$aPharmaceutical chemistry. 615 0$aIndustrial policy. 615 0$aDrug delivery systems. 615 14$aPharmaceutics. 615 24$aRegulation and Industrial Policy. 615 24$aDrug Delivery. 676 $a615.19 700 $aGhante$b Minal$01733066 701 $aPotdar$b Manohar$01733067 701 $aBhusari$b Vidhya$01733068 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910842488703321 996 $aModern Aspects of Pharmaceutical Quality Assurance$94148119 997 $aUNINA