Printed Pages: 01 Sub Code:BP-806ET
Paper Id: 231221 Roll No.
B PHARMA
(SEM VIII) THEORY EXAMINATION 2022-23
QUALITY CONTROL AND STANDARDIZATION OF HERBALS
Time: 3 Hours Total Marks: 75
Note: Attempt all Sections. If require any missing data; then choose suitably.
SECTION A
1. Attempt all questions in brief. 2 x 10 = 20
(a) What is the significance of extractive value?
(b) Name the methods used for determination of moisture content in crude drugs.
(c) What is the requirement of Quality Assurance in Herbal Drug Industry?
(d) Give the full form of GLP and cGMP.
(e) What do you mean by safety and efficacy of crude drugs?
(f) Mention the conditions for accelerated stability studies of crude drugs.
(g) Express the meaning of ‘Pharmacovigilance’.
(h) What do you understand by terms ‘chemical markers’ and ‘biological markers’.
(i) Mention the role of HPTLC in standardization of herbal drugs.
(j) Write a note on Herbal Pharmacopoeia.
SECTION B
2. Attempt any two parts oQf thP
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e following: 10 x 2 = 20
(a) Discuss the methods for evaluation of commercial crude drugs intended for use.
(b) Discuss the GMP in traditional system of medicine.
(c) Describe the ICH guidelines for quality control of herbal drugs.
SECTION C
3. Attempt any five parts of the following: 7 x 5 = 35
(a) Discuss the physico-chemical parameters for standardization of herbal drugs.
(b) Outline the Research Guidelines for Evaluating the Safety and Efficacy of Herbal
Medicines.
(c) Describe the methods for q u|a l1
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ity assurance in herbal drug industry.
(d) Explain the document preparation for new drug application.
(e) Discuss the protocol for the stability testing of herbal medicines.
(f) Explain the regulatory requirements for herbal medicines.
(g) Summarize the significance of markers in study of Phytomolecules.
QP23DP1_290 | 10-01-2023 13:20:40 | 117.55.242.132