JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy IV Year QUALITY CONTROL AND STANDARDIZATION OF HERBALS 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
Give a short note on the Organoleptic Evaluation.
Answer
Organoleptic evaluation is the qualitative assessment of herbal drugs based on sensory characteristics such as color, odor, taste, size, shape, and texture. This method serves as the initial step in the identification and authentication of crude drugs, providing a rapid, non-instrumental means to detect gross adulteration or deterioration by comparing the sample against established pharmacognostic standards.
Write a short note on basic tests for crude drugs.
Answer
Basic tests for crude drugs are essential for preliminary evaluation to ensure quality, purity, and safety before advanced analytical techniques are applied. These tests primarily focus on organoleptic, microscopic, and physical evaluation.
- Organoleptic evaluation: Involves the use of sensory organs to assess the drug's color, odor, taste, size, shape, and fracture characteristics. This provides a quick, initial identification of the specimen.
- Microscopic evaluation: Utilizes light microscopy to examine internal cellular structures, such as trichomes, stomata, starch grains, and calcium oxalate crystals. This is critical for detecting adulterants and confirming the botanical identity of powdered drugs.
- Physical evaluation: Includes quantitative measurements such as moisture content, ash values (total ash, acid-insoluble ash, water-soluble ash), and extractive values (alcohol-soluble or water-soluble). These tests help determine the presence of foreign organic matter, inorganic impurities, and the concentration of active constituents.
What are the factors affecting quality of herbal drugs.
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List out the herbal processing methods?
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What do you mean by EU and ICH guidelines?
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Write a short note on importance of herbal therapy.
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Briefly explain about the concept of the new drug application.
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What is the purpose of Filing Form 10?
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Write a short note on the role of regulatory in pharmacovigilance.
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Who are the regulatory bodies for pharmacovigilance in India?
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Part B
Explain in detail about the WHO guidelines for the quality control of herbal drugs.
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Write in detail about the evaluation process of commercial crude drugs.
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Discuss about the basic test procedures for pharmaceutical drug Substances.
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What are the different methods of evaluation of crude drugs?
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Describe the role of Quality assurance in herbal drug industry.
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Write about the WHO Guidelines on GACP for Medicinal Plants in detail.
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What is GMP in traditional system of medicine?
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Enumerate the WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines.
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Enunciate the ICH guidelines for the quality control of herbal drugs.
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Enlist the quality control parameters of herbal drugs?
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What are the evaluation techniques for the herbal drugs?
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Describe the research Guidelines for Evaluating the Safety of Herbal drugs.
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Explain the application of various chromatographic techniques in standardization of herbal products.
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Summarize the steps involved in the preparation of documents for new drug application.
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What are the provisions of Drug and Cosmetic Act?
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Mention the Good Manufacturing Practices in Drug and Cosmetic Act?
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What are chemical markers in herbal medicine?
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Discuss the role of chemical and biological markers in standardization of herbal products.
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What are the different types of herbal pharmacopoeia?
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Write a detailed note on the comparison of various Herbal Pharmacopoeias.
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