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Pharmaceutical Quality Assurance

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Pharmaceutical Quality Assurance plays a major role in product development. In fact, this is involved in the entire process of the drug use right from research and development, manufacturing, storing and distribution. Hence, extensive knowledge of quality assurance is needed for effective and efficient functioning.

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SKU: P6006 Categories: , ,
ISBN 978-93-88756-69-3
Publishers R. Narain Publishers & Distributors
Author Pranjal Kumar Singh, Alok Kumar Singh, Dr. Sukhbir Singh & Dr. Neelam Sharma
Binding Paperback
Edition 1/e
Price 230
Year 2023
Pages 200
Subject Pharmaceutical Quality Assurance


Weight 250 g

Table of Content

  1. Introduction of Quality Assurance
  2. Good Manufacturing Practices (GMP) for
  3. Pharmaceutical Products
  4. Quality Management
  5. Principles of Quality Management
  6. Total Quality Management (TQM)
  7. ICH Guidelines
  8. Quality by Design (QBD)
  9. ISO 9000
  10. NABL Accreditation
  11. Organization and Personnel
  12. Personnel
  13. Training
  14. Personal Hygiene
  15. Premises
  16. Plant Layout
  17. Sanitation and Hygiene
  18. Environmental Control
  19. Utilities & Services
  20. Control of Contamination
  21. Equipments and Raw Materials
  22. Raw Material
  23. Containers
  24. Good Laboratory Practices
  25. Organization and Personnel
  26. Facilities
  27. Equipment
  28. Test, Control and Reference Substance
  29. Protocol and Conduct of Nonclinical Laboratory Study
  30. Records and Reports
  31. Disqualification of Testing Facilities
  32. Complaints
  33. Evaluation of Complaints
  34. Handling of Return Goods
  35. Recalling
  36. Waste Disposal
  37. Batch Formula Record
  38. Master Formula Record
  39. Standard Operating Procedure (SOP)
  40. Quality Audit
  41. Quality Review
  42. Quality Documentation
  43. Documents
  44. Distribution Records
  45. Calibration
  46. Validation
  47. Validation Master Plan
  48. Qualification
  49. Qualification of UV-Visible Spectrophotometers
  50. Good Warehouse Practices
  51. Material Management


Salient features include:

  1. This book has been written to provide theoretical information in an operational manner about procedures, techniques and methods used to maintain the standard as per GMP and WHO guidelines.
  2. Quality assurance as a subject is taught under various core subjects so this book has been designed to simplify concepts of quality assurance.
  3. The Pharmacy Council of India has revised the syllabus for pharmacy and also made it more relevant to the Industry. The chapters are arranged as per latest syllabus of PCI. Flow charts, tables and figures have been used throughout the book for better understanding of the content.

3 reviews for Pharmaceutical Quality Assurance

  1. 5 out of 5

    Naveen Shah

    Excellent books for scoring students.All the books help alot to all professional students in a best possible manner.

  2. 5 out of 5

    harsh patal

    R.Narain Publishers are giving a real platform among the students by providing books of different streams. These books have updated context of knowledge which will help the students for gathering required concepts of studies.

  3. 5 out of 5

    Pooja Thakur

    Excellent and latest informative study…

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