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Quality Assurance Book B.Pharm 6th Semester
Quality Assurance Book B.Pharm 6th Semester
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Syllabus
Module 01 10 Hours
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.
Module 02 10 Hours
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.
Module 03 10 Hours
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.
Module 04 08 Hours
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.
Module 05 07 Hours
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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