JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV QUALITY CONTROL AND STANDARDIZATION OF HERBALS Previous Question Paper (January/February - 2023 - R17)

B.Pharmacy | IV | IV-I | R17 | January/February - 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

125 marks
a

What are the basic tests for quality control of herbal drugs?

2 marks

Answer

The basic tests for quality control include organoleptic evaluation, microscopic examination, physical constants (such as ash values, extractive values, and moisture content), phytochemical screening, and chromatographic analysis (TLC, HPTLC).

b

What is ash value? Write the importance of ash value.

3 marks

Answer

Ash value represents the inorganic residue remaining after the incineration of plant material. It is important because it provides a measure of the total mineral content, helps detect adulteration with earthy matter or sand, and identifies the presence of inorganic impurities or metallic salts.

c

Enumerate GLP requirements for traditional system of medicine.

2 marks

Answer

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d

Write in short WHO guidelines on cGMP.

3 marks

Answer

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e

Write EU guidelines for quality control of herbal drugs.

2 marks

Answer

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f

Give research guidelines for safety of herbal drugs

3 marks

Answer

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g

Write the application of GC in standardization of herbal drugs

2 marks

Answer

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h

Explain complaints and recall as per GMP.

3 marks

Answer

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i

What are WHO guidelines for safety monitoring of herbal medicine.

2 marks

Answer

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j

Mention important regulatory requirements for herbal medicines.

3 marks

Answer

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Part B

210 marks
a

Explain advanced analytical methods for evaluation of crude drugs.

5 marks

Answer

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b

Give basic tests for identification of alkaloids and glycosides.

5 marks

Answer

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OR
310 marks
a

Discuss WHO guidelines for quality control of herbal drugs.

5 marks

Answer

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b

Describe the method to determine heavy metals in herbal preparations.

5 marks

Answer

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410 marks
a

What is cGMP? And discuss WHO guidelines on cGMP of herbal drugs.

5 marks

Answer

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b

Write a note on quality assurance in herbal industry. Explain the importance of cGMP.

5 marks

Answer

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OR
510 marks
a

Explain infrastructural requirements for herbal industry as per GMP guidelines.

3 marks

Answer

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b

List out WHO guidelines for assessment of herbal drugs.

3 marks

Answer

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c

Explain factors effecting cultivation and collection of medicinal plants as per GACP.

4 marks

Answer

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610 marks
a

Write a note on ethical consideration on the research of herbal medicine.

5 marks

Answer

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b

Explain ICH guidelines for assessment of quality of herbal drugs.

5 marks

Answer

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OR
710 marks
a

Discuss research guidelines for evaluation of safety and efficacy of herbal drugs.

5 marks

Answer

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b

Explain the importance of European medicine agency on quality of herbal drugs.

5 marks

Answer

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810 marks
a

Explain the application of HPLC & TLC for standardization of herbal drugs.

5 marks

Answer

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b

Explain the importance of HPTLC in standardization of herbal drugs.

5 marks

Answer

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OR
910 marks
a

Write a note on document preparation for new drug application.

5 marks

Answer

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b

Explain GMP requirements for herbal drugs as per Drugs and Cosmetics Act.

5 marks

Answer

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1010 marks
a

Write the WHO guidelines for safety monitoring of herbal drugs in pharmacovigilance systems.

5 marks

Answer

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b

Explain role of chemical markers in standardization of herbal drugs.

5 marks

Answer

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OR
1110 marks
a

Discuss the safety of herbal drugs as per various pharmacopoeias.

5 marks

Answer

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b

Mention regulatory requirements for herbal drugs.

5 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 IV-I, January/February - 2023, R17.

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