Quality Control and Standardization of Herbals (B pharm 8 sem QB)

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B pharmacy 8-semester subject Quality control and standardization of herbals Question bank, it contains all the important questions of the syllabus and this released by rguhs.

10 MARKS question for Quality Control and Standardization of Herbals

  1. Explain the advanced analytical methods of evaluation of crude drugs
  2. Describe the applications of HPLC and HPTLC techniques in the standardization of herbal products.
  3. Explain briefly the current good manufacturing practices (cGMP) for herbal drugs
  4. Describe predictable changes in the herbal medicinal products on storage Explain the methods for evaluating the same?
  5. Describe the pharmacological and toxicological evaluation of herbal drugs
  6. What are the best practices in the collection of herbal raw material as per GACP? Explain with examples
  7. Explain layout of factory premises and working area of different departments as per GMP
  8. Explain the toxicological and biological method of evaluation of crude drugs
  9. Explain in detail stability testing methods and protocols for stability testing of herbal products.
  10. Explain Physico-chemical evaluation for the quality control of herbal drugs as per WHO
  11. Discuss the factors affecting the cultivation and collection of medicinal plants as per GACP
  12. What is stability? Describe methods for stability testing of herbal products?
  13. Explain the factor affecting the collection and processing of medicinal plants as per GACP
  14. What are the challenges in the stability testing of herbal products? Explain a suitable protocol for testing the stability of a herbal drug
  15. Explain applications of TLC, HPTLC, and HPLC in the herbal product standardization with suitable examples
  16. Write in detail botanical and physical methods for quality control of herbal products as per WHO
  17. What is cGMP? Discuss the WHO Guidelines on cGMP of Herbal drugs
  18. List out the WHO guidelines for the assessment of herbal drugs. Explain the determination of microbial contamination in herbal drugs
  19. What is cGMP? Discuss the WHO Guidelines on cGMP of Herbal drugs
  20. Describe Stability testing protocols for herbal medicinal products
  21. List out the WHO guidelines for the assessment of herbal drugs. Explain the determination of heavy metals in herbal drugs
  22. Explain the importance of HPLC & HPTLC standardization of herbal products
  23. Explain the infrastructural requirements under GMP for the herbal industry
  24.  What do you understand by ‘Quality assurance in herbal Industry’? Explain the importance of GMP in the Herbal Industry.
  25. What is stability testing? Explain the different methods for stability testing of herbal drugs in detail.
  26. Define- cGMP, GLP, and GACP. Explain the WHO guidelines for current good  manufacturing practices (cGMP) for herbal medicine
  27. What is Chromatography? Explain the importance of HPTLC and HPLC in the standardization of herbal drugs

5 MARKS Questions for Quality Control and Standardization of Herbals

  1. Explain the method to determine the microbial and aflatoxin content in the herbal drugs
  2. Describe the method of determination of heavy metals in the herbal preparations
  3. Explain in brief about good agriculture practice of herbal drugs
  4. Write a note on ethical consideration on the research of herbal medicine
  5. Explain in brief nonclinical studies relevant to herbal medicine research
  6. Enlist and explain the documents required for export registration
  7. Explain the factors affecting the stability of herbal drugs
  8. What are the regulatory requirements of herbal medicines in India
  9. What is a herbal monograph? Describe the various parameters in a herbal monograph
  10. Write a descriptive note on Pests and pest control methods
  11. What is the importance of physical constants in the evaluation of herbal dugs
  12. Explain the importance of the European medicine Agency-Guideline on the quality of herbal medicinal products
  13. Write a note on the assessment of the case report for safety monitoring
  14. Define and classify markers with examples
  15. Explain the application of HPLC for the standardization of a herbal drug
  16. Describe the D&C Act provisions for herbal and traditional products
  17. Give the application of quantitative microscopy in the evaluation of herbal raw material
  18. Explain complaints and recalls as per GMP
  19. Give the applications of chromatography in the standardization of herbal drugs
  20. Explain the procedure and significance of microscopic in the evaluation of herbal drugs
  21. Give the guidelines for evaluation of the safety of herbal medicine
  22. Write a note on regulatory requirements of herbal medicine of EU
  23. Explain briefly the good agriculture practices of herbal drugs
  24. Enlist the documents required for export registration
  25. Write a note on the traditional knowledge of herbal medicine
  26. What are the WHO guidelines for safety monitoring of herbal drugs
  27. Explain the infrastructure requirement for herbal Industry
  28.  Give the application of TLC and HPTLC in the standardization of herbal products.
  29. Explain the role of chemical markers in the standardization of herbal drugs with suitable examples
  30.  Explain the identification and estimation of pesticide residues in plant products
  31.  Give the basic tests for Alkaloids and Glycosides in herbal products.
  32.  Outline briefly the GMP requirement for the manufacture of herbal and traditional products
  33.  Give a protocol for clinical trials in herbal medicine.
  34.   Write briefly the guidelines of the European Union for medicinal preparations
  35.   What are adverse drugs reactions? Explain the challenges in monitory adverse drugs reaction in herbal medicine
  36. Write the silent features for GMP for herbal medicine
  37.  Write a note on the document preparation for new drug applications
  38. Describe GMP requirement of equipment qualification and validation
  39. What is standardization? Explain the application of HPTLC as a method for standardization.
  40. Give the test for heavy metals in the plant products
  41. Write the chemical tests for identification of secondary plant metabolite
  42. Describe marker-based standardization of plant products
  43. Write a note on ICH guideline for quality control of herbal medicinal products
  44. What is EMA? Explain its importance in the assessment of herbal medicinal products
  45. Compare and contrast between Ayurvedic and herbal pharmacopeia
  46. What are adverse drugs reactions? Explain the safety monitoring of herbal medicine
  47. Give a clinical trial protocol for safety evaluations.
  48. Explain the drug regulatory requirement of India for natural products
  49. Explain documentation for GMP of herbal Drugs
  50. Explain Mutangenicity by any 2 different methods.
  51. Explain the use of advanced chromatographic techniques for evaluation and standardization of herbal drugs
  52. Write a note on the stability testing protocols for herbal drugs
  53. Write a note on good practices for harvesting and storage of herbal medicinal products
  54. What is the scope of EMA guidelines on quality control of herbal medicinal products?
  55. Write a note on ICH guidelines for quality control of herbal drugs.
  56.   Explain the role of chemical and biological   markers in the standardization of herbal products
  57. Explain the research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines in Brief
  58. Explain documentation for GMP of herbal Drugs
  59. Write a note on EU regulatory requirements for herbal medicines.
  60. Write a note on good practices for harvesting and storage of herbal medicinal products
  61. What are the challenges in conducting shelf-life studies for herbal medicinal products?
  62. Write a note on  EMA guidelines
  63. Explain the WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
  64. Write a note on the stability of herbal products
  65. Explain the role of markers in the standardization of herbal products
  66. Explain the research Guidelines for evaluating the safety of herbal medicines
  67. Write a note on regulatory requirements for herbal medicines in India.
  68. Explain the method to determine the aflatoxin content in the herbal drugs
  69. Write a note on any two methods for the determination of moisture content in herbal drugs
  70. What are the ethical considerations in the research of herbal medicine?
  71. Write a note on good practices for the storage of herbal medicinal products
  72. Write a note on GLP in the traditional system of medicine.
  73. Explain the necessity for the evaluation of the safety and toxicity of herbal drugs. What are the WHO guidelines for the same?
  74. What is a traditional system of medicine? What are the GLP requirements in the traditional system of medicine?
  75. Explain the good agricultural and collection practices for medicinal plants as per WHO guidelines.
  76. Explain the need for ICH guidelines in the quality control of herbal drugs.
  77. Explain the scientific data collected and compiled as per EU guidelines on herbal drugs, preparations, and combinations.
  78. Write a note on preparation of documents for new drug application
  79. How are herbal drugs regulated in India? Explain
  80. Give examples of adverse or drug-related problems of herbals and traditional systems of medicine and explain the importance of pharmacovigilance
  81. What are the predictable changes in herbal drugs upon storage? How will you test and analyze these changes?
  82. Medicinal plant materials are not safe always” – explain the statement with examples. How do you evaluate the safety of medicinal plants?
  83. Describe WHO guidelines on GACP for medicinal plants.
  84. Explain the different analytical methods for the evaluation of herbal drugs. Add a note on advanced methods of evaluation.
  85. Explain the protocol for stability testing of herbal drugs.
  86. How does the European Medicines Agency’s (EMA) committee assess the scientific data on herbal preparations to support the harmonization of the European market?
  87. Mention the different types of Herbal Industries. Explain the importance of WHO guidelines for quality assurance in these herbal Industries.
  88. What are the challenges in monitoring the safety of herbal drugs? Explain the guidelines given by WHO for monitoring the safety of herbal drugs.
  89. Explain the various parameters that are studied for testing the stability and Shelf life of an herbal drug.
  90. Write a note on the botanical evaluation of crude drugs.

2 MARKS Question for Quality Control and Standardization of Herbals

  1. List out the various WHO guidelines for the safety of herbal drugs
  2. Enumerate the GLP requirements for the traditional system of medicine.
  3. List out the contents of a protocol for a clinical trial for the safety of herbal medicines.
  4. Give examples of herbal drug interactions
  5. Explain the importance of chemical and biological markers.
  6. Define swelling index and give its significance
  7. Define GACP and write its importance.
  8. Enumerate the research guidelines for evaluating the efficacy of herbal medicines.
  9. What are the requirements for personnel hygiene as per GMP for herbal drugs?
  10. Define standardization and write its importance.
  11. Define processed and finished herb as per WHO
  12. Define shelf life and give its significance
  13. Define Adverse drug events and list out any two potential adverse events
  14. What is the acceptable residual limit (ARL) in herbal drugs
  15. List the content of the herbal monograph
  16. Write the importance of Ash Value
  17. What is chromatographic fingerprinting?
  18. Define acute and chronic toxicity studies
  19. What are weedicides give any two examples?
  20. What is the difference between moisture content and loss on drying?
  21. Name the various parameters for evaluation of commercial drugs intended for use
  22. Give objectives of GACP and GLP
  23. Define HMPC and EMA
  24. Name the different stability testing methods with their importance
  25. Write a note on chemical markers with examples.
  26. List out the basic chemical tests for pharmaceutical substances
  27. Define Pharmacovigilance and give its importance
  28. Give anyone a test for teratogenicity.
  29. Write a short note on the significance of GMP.
  30. Define Evaluation and standardization
  31. Explain Complaints and Recall as per GMP
  32. Enlist sources of safety reports
  33. Define a) standardization b) Shelf life
  34. Enlist tests for purity of herbal raw material
  35. How do you estimate the number of starch grains in ginger powder?
  36. Enlist Edaphic factors affecting cultivation
  37. What are the objectives of the Herbal Medicinal Product Committee of EMA?
  38. Effect of Auxins on crops
  39. Expand, GACP, GMP, cGMP, and GLP
  40. What is oxidation
  41. Define chromatographic fingerprinting
  42. Define monographic analysis
  43. Give the objectives of HMPC
  44. Give the significance of ICH
  45. Give the method of sampling of herbal drugs as per WHO guidelines
  46. Define GACP, GLP, GMP, cGMP
  47. What is quantitative microscopy
  48. Enlist the components of HPLC
  49. What is racemization
  50. Write a short note on control of excipient
  51. Define a) Drug Extract Ratio b) Genuine herbal preparation
  52. What is AYUSH? Explain its significance
  53. Compare and contrast between Analytical and Active marker
  54. How does FDA regulate natural products in the US
  55. Give any two tests for identification Tannins
  56. Differentiate between TLC and HPTLC
  57. What is bitter value?
  58. Write the significance of Ash Value
  59. List out toxicological evaluation tests
  60. Significance of extractive values
  61. Define monograph analysis
  62.  Give the protocol for evaluation of drug safety in animals.
  63.  Define qualification and validation as per GMP
  64.  Write a note on the Drying of crude drugs
  65.   What are the adsorbents used in TLC
  66.   Importance of Extractive value
  67.  Define LOD
  68.   Enumerate the GLP requirements for the traditional system of medicine.
  69.  Define Fingerprinting analysis
  70. Application of Gas chromatography in standardization of herbal products
  71. Give the importance of heavy metal determination in herbal drugs
  72. Give the protocol for evaluation of drug safety in animals.
  73. Write a note on personal hygiene as per GMP
  74. Define Pesticide residue
  75. Give the components of HPLC
  76. Importance of Extractive value
  77. Scope of Herbal Drug Industries
  78. Enumerate the GLP requirements for the traditional system of medicine.
  79. EU guidelines for quality control of herbal drugs
  80. Define astringency content
  81. What are the needs for the evaluation of commercial crude drugs?
  82. Explain the factors affecting the quality of herbal drugs
  83. What is the role of EMA in the quality control of herbals?
  84. What are the differences between HPLC and HPTLC?
  85. What are the different climatic zones for stability testing
  86. What provisions are given for herbal drugs in the Drugs and cosmetic act?
  87. What is an herbal monograph? give example
  88. Define different types of markers in standardization with examples.
  89. What guidelines are given for testing the efficacy of herbal preparations?
  90. Write a note on authentication of medicinal plant.
  91. What is Pharmacological evaluation?
  92. What is Chemo microscopy?
  93. Give the significance of ICH guidelines for the safety of herbal
  94. Define quality control and standardization.
  95. What are the differences between TLC and HPTLC?
  96. Name the different types of evaluation of crude drugs.
  97. What is a herbal dossier?
  98. What is an accelerated stability study?
  99. What are physical constants?
  100. What is chromatographic fingerprinting?

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