Syllabus Pharmaceutical Quality Assurance UNIT - I • 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 and ISO14000 : Overview, Benefits, Elements, steps for registration. • NABL accreditation : Principles and procedures. (Chapter - 1) UNIT-II • 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. • Equipments and raw materials : Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. (Chapter - 2) UNIT- III • 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. (Chapter - 3) UNIT-IV • 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. (Chapter - 4) UNIT- V • 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. (Chapter - 5)
