UNIQUE SERIES AKTU Syllabus
BP505T

Pharmaceutical Quality Assurance (Theory)

L-T-P3-0-0 Credits3 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 5 (Core)

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Syllabus

5 units · 45 lecture hours
Unit1

Unit 1: Quality Assurance and Quality Management Systems

10 hrs
  • Quality Assurance and Quality Management concepts: Definition and concepts of Quality Control, Quality Assurance, and GMP
  • Total Quality Management (TQM): Definition, elements, and philosophies
  • ICH Guidelines: Purpose, process of harmonization, overview of QSEM with special emphasis on Q-series guidelines
  • Quality by Design (QbD): Definition, overview, elements of QbD program, and tools
  • ISO 9000 and ISO 14000: Overview, benefits, elements, and steps for registration
  • NABL Accreditation: Principles and procedures
Unit2

Unit 2: Organization, Personnel, Premises, and Materials Management

10 hrs
  • Organization and Personnel: Responsibilities, training, hygiene, and personal records
  • Premises: Design, construction, plant layout, maintenance, sanitation, environmental control, utilities, and control of contamination
  • Equipment and Raw Materials: Equipment selection, User Requirement Specifications (URS), handling and maintenance of raw materials
  • Warehousing: Good warehousing practices and materials management
Unit3

Unit 3: Quality Control and Good Laboratory Practices

10 hrs
  • Quality Control Tests for Formulations: In-process and finished product quality control tests for tablets, capsules, ointments, creams, ophthalmic and parenteral preparations
  • Quality Control of Raw Materials and Packaging Materials: Tests for raw materials, containers, rubber closures, and secondary packing materials
  • Good Laboratory Practices (GLP): General provisions, organization and personnel, facilities and equipment, ALCOA principles, reference standards, testing facility operations, records and reports, and disqualification of testing facilities
Unit4

Unit 4: Documentation, Complaints, and Product Recall

8 hrs
  • Documentation in the Pharmaceutical Industry: Batch Formula Record, Master Formula Record, Drug Master File, SOPs, quality audits, preparation, handling, archival, and distribution of records
  • Complaints and Product Recall: Handling of complaints, evaluation of complaints, returned goods, recalls, and waste disposal
Unit5

Unit 5: Calibration and Validation

7 hrs
  • Calibration and Validation: Introduction, definitions, importance, and general principles Calibration of weights and measures, pH meter Qualification of UV-Visible spectrophotometer, electronic balance, IR spectrophotometer, and HPLC
  • Analytical Method Validation: General principles of analytical method validation as per ICH Q2 guidelines
Course Objectives6 points
  • The objectives of this course are to:
  • Introduce the concepts and systems of pharmaceutical quality management
  • Provide an overview of regulatory frameworks governing pharmaceutical quality.
  • Familiarize students with organizational, infrastructural, and operational requirements of pharmaceutical manufacturing and quality control.
  • Explain quality control testing of pharmaceutical products
  • Understand the documentation, validation, calibration, and data integrity essential for regulatory compliance.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the concepts of QA, QC, GMP, GLP and modern Quality Management Systems.
  2. CO2Apply TQM, QbD, and ICH guidelines to ensure consistent pharmaceutical quality.
  3. CO3Understand requirements related to personnel, premises, equipment, materials, and documentation.
  4. CO4Describe quality control testing of pharmaceutical products.
  5. CO5Explain calibration, qualification, and analytical method validation as per regulatory guidelines.
Recommended References (Preferably latest editions)4 books
  1. Godfrey, A. B. and Juran, J. M. Juran’s Quality Handbook. McGraw-Hill Education.
  2. Organisation of Pharmaceutical Producers of India. Quality Assurance Guide. OPPI.
  3. Weinberg, S. Good Laboratory Practice Regulations. Marcel Dekker.
  4. World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. World Health Organization. Course Title Course Type

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Official AKTU syllabus

This subject is on page 136, 137, 138 of the original AKTU PDF.

Official AKTU syllabus PDF ↗