JNTU
JNTU B.Pharmacy III PHARMACEUTICAL QUALITY ASSURANCE Previous Question Paper (July - 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
List the tools and elements of Qbd.
Answer
The tools of Quality by Design (QbD) include Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Risk Assessment, Design Space, and Control Strategy. The key elements are systematic development, predefined objectives, and an emphasis on product and process understanding.
Give the concept of Quality control.
Answer
Quality Control (QC) is the operational technique and activity used to fulfill requirements for quality. It focuses on testing, monitoring, and inspection of raw materials, in-process products, and finished goods to ensure they meet established specifications before release.
Write note on the control of contamination.
Answer
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Discuss on GMP with respect to sanitation.
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Write a note on non-clinical laboratory.
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Give the GLP for test and control articles.
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How to handle return goods?
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Write a note on Quality audit.
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List the types of Validation.
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Write note on materials management.
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Part B
Write a short note on the concept of Total Quality Management?
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Explain briefly the various elements required for management of quality in pharmaceutical industry.
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Discuss the principles and procedure for NABL accreditation.
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Describe the process of harmonization of ICH guidelines.
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Discuss the responsibilities, training and hygiene of personnel records.
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Brief on the Purchase specifications and maintenance of stores for raw materials.
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Explain the quality control tests for containers, rubber closures and secondary packing materials.
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Discuss the concept, general provisions and protocols of GLP with reference to a Non-clinical laboratory study.
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Write detail note on master formula record and batch formula record.
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How to manage waste disposal?
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Discuss how complaints should be handled according to the GMP provisions?
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Elaborate recalling and handling of return goods.
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What is good warehousing practices? Describe briefly material management in a warehouse.
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Compare the general principles of calibration, qualification and validation.
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Describe calibration of UV-visible spectrophotometer.
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