Pharmaceutical quality assurance 6th sem important questions। Short & long Questions। Part-1।

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Today In this video I provide Biopharmaceutics and pharmacokinetics 6th semester important questions with solution pdf.


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Unit-I
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.

Unit-II
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
maintenance, purchase specifications and maintenance of stores for raw materials.
and raw materials: Equipment selection, purchase specifications,

Unit-III
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.

Unit-IV
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.

Unit-V
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.