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A Textbook of Pharmaceutical Quality Assurance


  • ISBN: 9789395596305
  • Published : May 2023
  • Book Language : English
  • Edition : First
  • Format : Paperback
  • Pages : 192
  • Category:
  • Download Book Ebook Link


A Textbook of Pharmaceutical Quality Assurance

It gives us an immense pleasure to bring out this simplified Textbook of the subject Pharmaceutical Quality Assurance, Semester – VI, Third Year. B. Pharmacy for students and teachers. The book comprises total five units exactly in the same order and with same contents as prescribed in syllabus of Pharmacy council of India.
This book provides detailed knowledge on Quality management concept through QbD, ICH and various Accreditation guidelines.
This subject deals with the application of quality control methods, validations and document maintenance in Pharmaceutical Industry.
The users of this book will understand about the organizational and personnel responsibilities.
Here, we expect good and positive response for this book by both the students and subject teachers for its quality and style of presentation, deep content and lucid explanatory language.

1. Chapter 
1.1 Quality Assurance and Quality Management Concepts
1. Definition and Concept of Quality Control
2. Quality Assurance and GMP
3. Introduction to Regulatory Agencies :
3.1. USFDA, 3.2. WHO, 3.3. CDSCO, 3.4. PIC/S.
1.2 Total Quality Management (TQM)
1. Introduction
2. Elements
3. Principles
4. Philosophies
1.3 ICH (International Conference on Harmonization) Guidelines
1. Introduction
2. Q-series guidelines
3. ICH stability testing guidelines
1.4 Quality by Design (QBD)
1. Introduction
2. Elements of QbD program
1.5 ISO 9000 & ISO14000: Overview, Benefits and Elements
1. Introduction
2. Elements of ISO
3. Benefits of ISO
1.6 National Accreditation Board for Testing and Calibration Laboratories (NABL) Accreditation
1. Introduction

2. Chapter 
Organization and Personnel, Premises, Equipments and Raw Materials
1. Introduction to Organization and Personnel
1.1 Responsibilities of different personnel in
a pharmaceutical industry
1.2 Training of personnel in pharmaceutical industries
1.3 Personal hygiene and personal records
2. Premises
2.1 Requirements of Pharmaceutical Manufacturing Premises
2.2 Areas of Pharmaceutical Manufacturing Premises
2.3 Maintenance Pharmaceutical Manufacturing Premises
3. Equipment and Raw material
3.1 Equipment and its Selection
3.2 Documents for equipment
3.3 Raw materials and its purchase specifications

3. Chapter 
Quality Control and Good Laboratory Practices
1. Introduction to Quality Control
2. Packaging
3. Quality control tests for packaging materials
4. Glass containers in Pharmaceutical Industry
4.1. Quality control tests for Glass containers
4.2. Quality control tests for Plastic containers
4.3. Quality control tests for Closures
4.4. Quality control tests for secondary packaging materials
4.5. Quality control tests for Cartoons
5. Good Laboratory Practices
5.1. Objectives and mission of GLP
5.2. Responsibilities in good laboratory practices
5.3. Basic elements of GLP
5.4. Principles of good laboratory practices
5.5. Disqualification of Testing Facilities
6. Responsibilities in good laboratory practices

4. Chapter 
Complaints and Document Maintenance in Pharmaceutical Industry
1. Introduction to Complaints
2. Product complaint data sheet
3. Steps involved in handling of complaints
4. Customer Complaint Record Book
5. Product Recall
6. Waste Disposal
7. Document Maintenance in Pharmaceutical Industry
8. Batch Formula Record
9. Quality Audit
10. Quality Review

5. Chapter 
Calibration and Validation
1. Introduction
2. Calibration Methods and Procedures
3. Qualification and its Types
4. Validation
5. General principles of analytical method validation
6. Warehousing
7. Materials management


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