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Semester V · PCI syllabus 2026
Pharmaceutical Quality Assurance
BP505T
3 credits
Theory
Coming soon
Unit 1: 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
- 4. Quality by Design (QbD): Definition, overview, elements of QbD
- 5. ISO 9000 and ISO 14000: Overview, benefits, elements, and steps for registration
- 6. NABL Accreditation: Principles and procedures
Unit 2: 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
Unit 3: 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
Unit 4: 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
Unit 5: 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
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