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AKTU Pharmaceutical Quality Assurance (Theory) (BP505T) Syllabus PDF – B.Pharm 5th Semester
Pharmaceutical Quality Assurance (Theory) BP505T
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Official AKTU syllabus of Pharmaceutical Quality Assurance (Theory) (BP505T) for B.Pharm 5th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Pharmaceutical Quality Assurance (Theory)
Download PDFBP505T · 3 credits · L-T-P 3-0-0
Course Objectives
- 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
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Explain the concepts of QA, QC, GMP, GLP and modern Quality Management Systems. |
| 2 | Apply TQM, QbD, and ICH guidelines to ensure consistent pharmaceutical quality. |
| 3 | Understand requirements related to personnel, premises, equipment, materials, and documentation. |
| 4 | Describe quality control testing of pharmaceutical products. |
| 5 | Explain calibration, qualification, and analytical method validation as per regulatory guidelines. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Quality Assurance and Quality Management Systems 1. Quality Assurance and Quality Management concepts: Definition and concepts of Quality Control, Quality Assurance, and GMP 2. Total Quality Management (TQM): Definition, elements, and philosophies 3. ICH Guidelines: Purpose, process of harmonization, overview of QSEM with special emphasis on Q-series guidelines | 10 hours |
- 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
| II | Organization, Personnel, Premises, and Materials Management 1. Organization and Personnel: Responsibilities, training, hygiene, and personal records 2. Premises: Design, construction, plant layout, maintenance, sanitation, environmental control, utilities, and control of contamination 3. Equipment and Raw Materials: Equipment selection, User Requirement Specifications (URS), handling and maintenance of raw materials 4. Warehousing: Good warehousing practices and materials management | 10 hours |
| III | Quality Control and Good Laboratory Practices 1. Quality Control Tests for Formulations: In-process and finished product quality control tests for tablets, capsules, ointments, creams, ophthalmic and parenteral preparations 2. Quality Control of Raw Materials and Packaging Materials: Tests for raw materials, containers, rubber closures, and secondary packing materials 3. 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 | 10 hours |
| IV | Documentation, Complaints, and Product Recall 1. Documentation in the Pharmaceutical Industry: Batch Formula Record, Master Formula Record, Drug Master File, SOPs, quality audits, preparation, handling, archival, and distribution of records 2. Complaints and Product Recall: Handling of complaints, evaluation of complaints, returned goods, recalls, and waste disposal | 08 hours |
| V | Calibration and Validation 1. 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 2. Analytical Method Validation: General principles of analytical method validation as per ICH Q2 guidelines | 07 hours |
Recommended References
- Godfrey, A. B. and Juran, J. M. Juran’s Quality Handbook. McGraw-Hill Education.
- Organisation of Pharmaceutical Producers of India. Quality Assurance Guide. OPPI.
- Weinberg, S. Good Laboratory Practice Regulations. Marcel Dekker.
- World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. World Health Organization.
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