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)

B. Pharmacy | IV Year | I Semester | R17 | July - 2023

Answer PaperPaper Code: 247AHMaximum Marks: 75Time: 3 Hours

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

1a

Give a short note on the Organoleptic Evaluation.

2 marks

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.

1b

Write a short note on basic tests for crude drugs.

3 marks

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.
1c

What are the factors affecting quality of herbal drugs.

2 marks

Answer

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1d

List out the herbal processing methods?

3 marks

Answer

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1e

What do you mean by EU and ICH guidelines?

2 marks

Answer

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1f

Write a short note on importance of herbal therapy.

3 marks

Answer

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1g

Briefly explain about the concept of the new drug application.

2 marks

Answer

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1h

What is the purpose of Filing Form 10?

3 marks

Answer

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1i

Write a short note on the role of regulatory in pharmacovigilance.

2 marks

Answer

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1j

Who are the regulatory bodies for pharmacovigilance in India?

3 marks

Answer

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Part B

210 marks
a

Explain in detail about the WHO guidelines for the quality control of herbal drugs.

5 marks

Answer

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b

Write in detail about the evaluation process of commercial crude drugs.

5 marks

Answer

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OR
310 marks
a

Discuss about the basic test procedures for pharmaceutical drug Substances.

7 marks

Answer

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b

What are the different methods of evaluation of crude drugs?

3 marks

Answer

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410 marks
a

Describe the role of Quality assurance in herbal drug industry.

5 marks

Answer

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b

Write about the WHO Guidelines on GACP for Medicinal Plants in detail.

5 marks

Answer

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OR
510 marks
a

What is GMP in traditional system of medicine?

3 marks

Answer

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b

Enumerate the WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines.

7 marks

Answer

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610 marks
a

Enunciate the ICH guidelines for the quality control of herbal drugs.

8 marks

Answer

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b

Enlist the quality control parameters of herbal drugs?

2 marks

Answer

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OR
710 marks
a

What are the evaluation techniques for the herbal drugs?

5 marks

Answer

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b

Describe the research Guidelines for Evaluating the Safety of Herbal drugs.

5 marks

Answer

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810 marks
a

Explain the application of various chromatographic techniques in standardization of herbal products.

6 marks

Answer

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b

Summarize the steps involved in the preparation of documents for new drug application.

4 marks

Answer

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OR
910 marks
a

What are the provisions of Drug and Cosmetic Act?

3 marks

Answer

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b

Mention the Good Manufacturing Practices in Drug and Cosmetic Act?

7 marks

Answer

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1010 marks
a

What are chemical markers in herbal medicine?

3 marks

Answer

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b

Discuss the role of chemical and biological markers in standardization of herbal products.

7 marks

Answer

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OR
1110 marks
a

What are the different types of herbal pharmacopoeia?

2 marks

Answer

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b

Write a detailed note on the comparison of various Herbal Pharmacopoeias.

8 marks

Answer

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About this paper

This page contains the question paper of QUALITY CONTROL AND STANDARDIZATION OF HERBALS from JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD for B. Pharmacy IV Year I Semester, July - 2023, R17.

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