Pharmaceutical Quality Assurance All Unit Notes

Bachelor of Pharmacy (B.Pharma)
Pharmaceutical Quality Assurance { BP606T }
All Unit Notes in One PDF

Unit 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 procedures

Unit 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.
Equipments and raw materials : Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

Unit 3
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

Unit 4
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.

Unit 5
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