Quality Assurance


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We are providing Quality Assurance Book for B.Pharm 6th Semester as per PCI by Thakur Publication. Pharmaceutical Book of quality assurance covered all important topics.

The PCI B.Pharm 6th semester Quality Assurance Book is an essential guide for pharmacy students studying quality assurance principles and practices. This comprehensive guide covers topics such as quality control, quality management, and regulatory affairs. It includes practical examples and case studies that make learning easy and enjoyable.


With this book, students can gain a comprehensive understanding of quality assurance and its applications in the pharmaceutical industry. Order your copy today and elevate your knowledge of quality assurance practices.

Prof. Dr. R. Sundhararajan, Dr.M.V.Kumudhavalli, Dr. (Mrs.) Minal T. Harde

ISBN No.: 978-93-89627-90-9


Module 01                                                                                          10 Hours

Quality Assurance and Quality Management Concepts

  • Definition and concept of Quality control, Quality assurance and GMP.

Total Quality Management (TQM)

  • Definition, elements, philosophies.

ICH Guidelines

  • Purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines.

Quality by Design (QbD)

  • Definition, overview, elements of QbD program, tools.

ISO 9000 & ISO14000

  • Overview, Benefits, Elements, steps for registration.

NABL Accreditation

  • Principles and procedures.

Module 02                                                                                          10 Hours

Organization and Personnel

  • Personnel responsibilities, training, hygiene and personal records.


  • Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.

Equipments and Raw Materials

  • Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

Module 03                                                                                          10 Hours

Quality Control

  • Quality control test for containers, rubber closures and secondary packing materials.

Good Laboratory Practices

  • General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation.
  • Test and Control Articles.
  • Protocol for Conduct of a Nonclinical Laboratory Study.
  • Records and Reports.
  • Disqualification of Testing Facilities.

Module 04                                                                                          08 Hours


  • Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal.

Document Maintenance in Pharmaceutical Industry

  • Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records.

Module 05                                                                                          07 Hours

Calibration and Validation

  • Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan.
  • Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.


  • Good warehousing practice, materials management.

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