JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy III Year PHARMACEUTICAL QUALITY ASSURANCE Previous Question Paper (February - 2023 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, Answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Write the principles of GMP.
Answer
The principles of GMP require that all manufacturing processes are clearly defined, systematically reviewed, and shown to be capable of consistently manufacturing products of the required quality. It also necessitates that all necessary resources, including qualified personnel, suitable premises, appropriate equipment, and approved materials, are provided to ensure compliance with quality standards.
Differentiate the Quality control and Quality Assurance.
Answer
Quality Assurance (QA) is a proactive, process-oriented system focused on preventing defects by ensuring that the entire manufacturing process is designed correctly. In contrast, Quality Control (QC) is a reactive, product-oriented system focused on identifying defects through testing and inspection of the finished product or raw materials.
Write about personal records.
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Write a note on control of contamination.
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Explain the testing facilities of GLP.
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What are the types of packaging? Mention its importance.
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What is SOP? What are its main components?
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Give a note on distribution records.
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Define validation. Write its importance.
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Define accuracy and precision.
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Part B
Write the definition, elements and philosophies of TQM.
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Explain the ICH stability testing guidelines.
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What is QbD? Write the definition, overview and tools.
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Explain the principles and procedure for NABL accreditation.
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Write the design, construction, plant layout, maintenance and sanitation in pharma industry.
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Explain the equipment selection, purchase specifications, maintenance.
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Discuss the general provisions, equipment of GLP.
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Explain in detail the maintenance of stores for raw materials.
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Explain the quality control tests for containers and rubber closures.
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Explain the handling of return goods, recalling and waste disposal.
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What is Quality review? Explain the Quality documentation in detail.
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Explain the master formula and batch formula records.
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Write general principles and types of validation? Give a note on validation master plan.
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What are good warehousing practices? Write its materials and management.
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Explain the calibration of pH meter.
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