Modern Aspects of Pharmaceutical Quality Assurance Developing & Proposing Application models, SOPs, practical audit systems for Pharma Industry
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...
| Other Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Singapore
Springer Nature Singapore
2024, 2024
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| Edition: | 1st ed. 2024 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 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.