B.Pharmacy 6th Semester Pharmaceutical Quality Assurance Notes & Important Question Answer
B.Pharma VIth Semester Pharmaceutical Quality Assurance Important Topics With All The Important Question And Answer Are Publish Here Download the Pdf and Give boost To Your Preparation. Stay Connected with us for your future examination all the important content will publish here . Your Full Pharmacy Syllabus will Be published here.
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Pharmaceutical Quality Assurance - 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.
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Pharmaceutical Quality Assurance - 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.
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B.pharma 6th Sem Pharmaceutical Quality Assurance Unit 2 Important Topics PDF:- Click Here
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Pharmaceutical Quality Assurance - 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.
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Pharmaceutical Quality Assurance - 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.
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Pharmaceutical Quality Assurance - 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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B.Pharmacy 6th Semester Pharmacology 3 Notes & Important Question Answer
B Pharmacy 6th Semester Notes
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