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

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Další autoři: Ghante, Minal (Editor), Potdar, Manohar (Editor), Bhusari, Vidhya (Editor)
Typ dokumentu: Kniha
Jazyk:Angličtina
Vydáno: Singapore : Springer, [2024]
Témata:
farmaceutická chemie
farmaceutický průmysl
systémy cílené aplikace léků
pharmaceutical chemistry
pharmaceutical industry
Drug Delivery Systems
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Obsah:
  • 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
  • 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)
  • 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
  • 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
  • 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

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