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Modern aspects of pharmaceutical quality assurancedeveloping & proposing application models, SOPs, practical audit systems for pharma industry /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Modern aspects of pharmaceutical quality assuranceedited by Minal Ghante, Manohar Potdar, Vidhya Bhusari.
其他題名:	developing & proposing application models, SOPs, practical audit systems for pharma industry /
其他作者:	Ghante, Minal.
出版者:	Singapore :Springer Nature Singapore :2024.
面頁冊數:	viii, 523 p. :ill., digital ;24 cm.
Contained By:	Springer Nature eBook
標題:	Pharmaceutical industryQuality control.
電子資源:	https://doi.org/10.1007/978-981-99-9271-3
ISBN:	9789819992713$q(electronic bk.)

Modern aspects of pharmaceutical quality assurancedeveloping & proposing application models, SOPs, practical audit systems for pharma industry /
Modern aspects of pharmaceutical quality assurancedeveloping & proposing application models, SOPs, practical audit systems for pharma industry /[electronic resource] :edited by Minal Ghante, Manohar Potdar, Vidhya Bhusari. - Singapore :Springer Nature Singapore :2024. - viii, 523 p. :ill., digital ;24 cm.

Chater 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.

The 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.

ISBN: 9789819992713$q(electronic bk.)

Standard No.: 10.1007/978-981-99-9271-3doiSubjects--Topical Terms:

301994
Pharmaceutical industry
--Quality control.

LC Class. No.: RS189

Dewey Class. No.: 615.19

Modern aspects of pharmaceutical quality assurancedeveloping & proposing application models, SOPs, practical audit systems for pharma industry /
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520 $a The 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.
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