B.Pharma Important Question
BP-803T(B)/PY-803(B)
Quality Control and Standardization of Herbals ,
VIII Sem, RGPV, B.Pharmacy
Unit-I Basic Tests for Drugs
Q.1 Describe the quality control of Herbal drugs as per WHO guidelines. (RGPV May 2022)
Q.2 Write the protocol for the evaluation of commercial crude drugs intended for use. (RGPV May 2022)
Q.3 Write a detail account on evaluation parameters for the evaluation of herbal dosage forms. (RGPV May 2022)
Q.4 Write a detail note on WHO guidelines for quality control of herbal drugs. (RGPV Jun 2020)
Unit-II Quality Assurance in Herbal Drug Industry
Q.1 Define standardization of Herbal product. Explain various parameters for the quality control of herbal drugs as per ICH guidelines. (RGPV May 2022)
Q.2 Write a detail note on assessment of efficacy of herbal medicines. (RGPV May 2022)
Q.3 Explain the WHO guidelines on current good manufacturing practices for herbal medicines. (RGPV Jun 2020)
Q.4 Discuss in brief about regulatory requirement for herbal medicines. (RGPV Jun 2020)
Unit-III EU and ICH Guidelines for Quality Control of Herbal Drugs
Q.1 Write a brief note on EU guideline for the quality control of herbal crude drugs. (RGPV May 2022)
Q.2 EU and ICH guidelines for quality control of herbal drugs. (RGPV Jun 2020)
Q.3 Write in detail about quality assurance in herbal drug industry of cGMP. (RGPV Jun 2020)
Unit-IV Stability Testing of Herbal Medicines
Q.1 What are the factors which affect the stability of a herbal formulation. (RGPV May 2022)
Q.2 Write a note on preparation of documents for new drug application and export registration as per GMP requirement. (RGPV May 2022)
Q.3 Discuss drugs C cosmetic act provision for the registration of new herbal formulation for intended use. (RGPV May 2022)
Q.4 Discuss stability testing of herbal medicines. Write the application of various chromatographic techniques in standardization of herbal products. (RGPV Jun 2020)
Q.5 Explain the process required for preparation of documents for new drug application and export registration. (RGPV Jun 2020)
Unit-V Regulatory Requirements for Herbal Medicines
Q.1 Write down the applications of various chromatographic techniques in standardization of herbal products. (RGPV May 2022)
Q.2 Write a exhaustive note on safety monitoring of herbal medicines in pharmacovigilance systems with reference to Indian Herbal Pharmacopoeias. (RGPV May 2022)
Q.3 Discuss in brief about WHO guideline on safety monitoring of herbal medicines in pharmacovigilance system. (RGPV Jun 2020)
Q.4 Explain the importance of chemical and biological markers in standardization of herbal products. (RGPV Jun 2020)
Extra Questions
Q.1 Write detail note on any two: (RGPV May 2022)
a) Role of biological markers in standardization of herbal products
b) WHO guidelines on GACP for medicinal plants.
c) GLP for medicinal plants
d) Application of chemical markers in standardization of herbal products.
— Best of Luck for Exam —
