Pharmaceutical Quality Assurance PDF Notes | B Pharmacy 6th Semester Noteskarts
Syllabus
Unit: 1
- Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, 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 material
- Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
Unit: 4
- Complaints: Complaints and evaluation of complaints, Handling of return good, recalling andwaste 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, validationmaster plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
- Warehousing: Good warehousing practice, materials management