Welcome to the dynamic domain of the 6th semester Pharmaceutical Quality Assurance, where we embark on a meticulous exploration of Pharmaceutical Quality Assurance. In this course, we dive into the critical processes that ensure the safety, efficacy, and reliability of pharmaceutical products. From meticulous manufacturing standards to rigorous quality control protocols, we unravel the intricate web of measures that uphold the highest standards in the pharmaceutical industry. Join us as we delve into the world of quality assurance, where precision and excellence converge to create a foundation of trust in every medication.
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 returned goods, recalling and
- waste disposal.
- Document maintenance in the pharmaceutical industry: Batch Formula Record, Master Formula
- Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
- documents, and 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
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