Pharmaceutical quality assurance 6th sem important questions। Short & long Questions। Part-2।

Hey! My name is Shahruddin Khan
Today In this video I provide Pharmaceutical quality assurance B Pharm 6th semester important questions : Short & long questions with solution pdf. (Part-2)
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#assurance
#herbal
#biotechnology #pharmacology
#medicinalchemistry
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#importantquestions
#bpharmacy
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#syllabus
#importantquestions
#exam
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-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-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.

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Hey Pharmacy Wala! 🎥📚
We’re in a bit of a time crunch here! 😅 The Pharma Marketing Management exam is just around the corner (June 29), and we’re feeling the pressure. Could you please upload a revision video for us? 🙏
And if you could throw in those notes as a PDF, we’d be forever grateful! 📝⏳
Thanks a bunch! You’re a lifesaver! 🌟
Best,
Your Stressed-Out Students 😅

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26:17 (GLP)

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