|Course: B Pharmacy -6th Semester/3rd Year|
|Name of the Subject: Pharmaceutical Quality Assurance (Theory)|
|Subject Code: BP606T|
|S. No.||Contents of the Topics||Domain||Time(Hrs)|
|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 procedure
|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.||Must Know||6|
|3.||Equipments and raw materials: Equipments selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.||Must Know||4|
|4.||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
|5.||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.
Nice to know
|6.||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
Nice to know
Syllabus | Pharmaceutical Quality Assurance (Theory) | B. Pharmacy
Home Syllabus | Pharmaceutical Quality Assurance (Theory) | B. Pharmacy