Pharmaceutical Quality Assurance

Quality assurance and quality control together play an important role in assuring the quality, safety and efficacy of a pharmaceutical product. Implementation of effective quality assurance policies is a key for the success of a product. Quality cannot be maintained by merely testing but needs to be built into the product. Since 21st century, there has been a growing awareness regarding quality of pharmaceutical products. As a result, pharmaceutical industries have adopted principles of total quality management, current good manufacturing practices and various harmonized guidelines and practices.

Pharmacy council of India has recommended the syllabus for undergraduates covering all the current quality practices and principles with a view of increasing awareness amongst students about these practices. The syllabus topics are varied and difficult to find in one single reference book. Keeping this requirement of students in mind, we have designed this textbook covering all the topics in sufficient depth. Although the book is written considering undergraduate students, it will also cater to the needs of postgraduates. The book covers all the quality principles including overview of total quality management, quality by design approach, cGMP principles emphasizing on personnel, equipments and material management, quality documentation, calibration and validation, complaints, good laboratory practices, quality control tests for packaging materials and also the overview of ICH guidelines, ISO 9000 and 14000, NABL accreditation procedures, etc. Since the documentation is an integral part of quality practices, various important document formats are also included as annexure to help to understand current industry standards.

1. Quality Management in the Drug Industry

2. ICH Guidelines

3. Quality by Design

4. ISO 9000 and ISO 14000

5. National Accreditation Board for Testing and Calibration Laboratories (NABL)

6. Organization, Personnel and Premises

7. Equipment and Raw Materials

8. Quality Control Tests for Packaging Materials

9. Good Laboratory Practices (GLPs)

10. Complaints

11. Document Maintenance in the Pharmaceutical Industry

12. Calibration and Validation

13. Annexure I to Annexure XIV

Bibliography

Index