Syllabus | Pharmaceutical Quality Assurance (Theory) | B. Pharmacy

Course: B Pharmacy -6th Semester/3rd Year
Name of the Subject: Pharmaceutical Quality Assurance (Theory)
Subject Code: BP606T
S. No. Contents of the Topics             Domain Time(Hrs)
1. 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 procedure

Must Know 10
2. Organization and personnel: Personnel responsibilities, training, hygiene and personal records. Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.  Must Know 6
3. Equipments and raw materials: Equipments selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. Must Know 4
4. 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

Must Know 10
5. Complaints: 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.

Must Know


Nice to know

6. 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.

Warehousing: Good warehousing practice, materials management


Must Know



Nice to know