| Description |
1 online resource (viii, 523 pages) |
| Contents |
Intro -- Preface -- Contents -- Chapter 1: Introduction: Quality Assurance from Perspective of Pharmaceutical Industry -- 1.1 Introduction -- References -- Chapter 2: Six Sigma Model in Pharma Industry: Part -- I -- 2.1 Six Sigma Part -- I -- 2.1.1 Introduction -- 2.2 Six Sigma -- 2.3 Six Sigma Methodology -- 2.4 Lean Six Sigma (LSS) -- 2.5 Six Sigma Vs. Lean Vs. cGMP -- References -- Chapter 3: Six-Sigma Model in Pharma Industry: Part -- II -- 3.1 Six Sigma: Part-II -- 3.1.1 Conception of the Six Sigma Principles -- 3.1.2 Quality by Design (QbD) -- 3.1.3 Elements of QbD |
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3.1.3.1 Quality Target Product Profile (QTPP) Which Recognizes Critical Quality Attributes (CQA) of Product -- 3.1.3.2 Identification of Critical Material Attributes (CMA) -- 3.1.3.3 Critical Process Parameters (CPP) Process Design as Well as Understanding (Strong Understanding of Scale-Up Techniques... -- 3.1.3.4 Control Strategy -- 3.1.3.5 Process Capability and Continuous Improvement -- 3.1.4 Pillars of QbD -- 3.1.4.1 Design Space(DS) -- 3.1.4.2 Control Space(CS)/DOE -- 3.1.4.3 Operating Space (OS) -- 3.1.5 QBD Methodology and Tools -- 3.1.5.1 Risk Assessment (RA) |
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3.1.5.2 Design of Experiment (DoE) -- 3.1.6 Types of DoE -- 3.1.6.1 Newly Arising Technologies -- 3.1.7 Process Analytical Technology (PAT) -- 3.1.8 PAT Components -- 3.1.8.1 Multivariate Statistical Process Control -- 3.1.8.2 Continuous Process Optimization and Knowledge Management -- 3.1.8.3 Process Analytical Chemistry Tools -- 3.1.8.4 Process Monitoring and Control -- 3.1.9 PAT Techniques -- 3.1.10 Continuous Manufacturing (CM) -- 3.1.10.1 Collaborative Continuous and End-to-End (E2E) Manufacturing -- 3.1.10.2 What Can Industry and Company Do? -- 3.2 Digitalization and Digital Twins |
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3.2.1 Industrial Revolutions and Industry 4.0 -- 3.2.1.1 Birth of Industry 5.0 -- 3.2.2 3D, 4D, and 5D Printing -- 3.2.2.1 3D -- 3.2.2.2 Pros of 3D Printing -- 3.2.2.3 4D -- 3.2.2.4 5D -- 3.2.3 Artificial Intelligence (AI), Image Analysis (IA), and Machine Learning (ML) Including Deep Learning (DL) -- 3.2.4 Supply Chain Management and Green Supply Chain Management -- 3.2.4.1 Operational Excellence -- Continuous Improvement (CI) -- References -- Chapter 4: Developing a Practical Audit System for a Pharmaceutical Industry Based on Six System Inspection Model -- 4.1 Introduction |
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4.1.1 Production System -- 4.1.2 Facilities and Equipment System -- 4.1.3 Laboratory Control System -- 4.1.4 Materials System -- 4.1.5 Packaging and Labeling System -- 4.1.6 Quality System -- 4.2 Consolidated Information -- 4.3 Development of Seventh System -- 4.3.1 Promote Improvement [ISO-10.3] -- 4.4 Audit and Checklist Format -- References -- Chapter 5: Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries -- 5.1 Introduction -- 5.1.1 Regulatory Audits -- 5.1.2 Types of Audits -- 5.1.3 The Ten Steps in the Pharma Audit Process -- 5.1.4 Remote Auditing |
| Summary |
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 |
| Notes |
Description based upon print version of record |
| Subject |
Pharmaceutical industry -- Quality control
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| Genre/Form |
Electronic books
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| Form |
Electronic book
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| Author |
Ghante, Minal
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Potdar, Manohar
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Bhusari, Vidhya
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| ISBN |
9789819992713 |
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9819992710 |
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