Introduction: This quiz collection focuses on the WHO guidelines for quality assessment of herbal drugs, designed specifically for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). The questions cover core WHO recommendations including Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP), identity and purity testing, chromatographic fingerprinting, reference standards, contaminants (heavy metals, pesticides, mycotoxins), microbial limits, DNA-based authentication, sampling, stability and documentation. Each MCQ aims to deepen understanding of regulatory expectations and practical laboratory approaches used to ensure safety, efficacy and consistency of herbal medicines. Use these questions to test and reinforce advanced concepts required for quality assurance in herbal drug development.
Q1. What is the primary purpose of the WHO guidelines for quality assessment of herbal drugs?
- To provide traditional healers with new formulations
- To offer internationally accepted guidance to ensure the safety, efficacy and quality of herbal medicines
- To replace national pharmacopoeias with a single global pharmacopoeia
- To mandate specific marketing claims for herbal products
Correct Answer: To offer internationally accepted guidance to ensure the safety, efficacy and quality of herbal medicines
Q2. Which WHO document specifically addresses manufacturing requirements for herbal medicines?
- WHO Good Agricultural and Collection Practices (GACP) for medicinal plants
- WHO Good Clinical Practice (GCP) guidelines
- WHO Good Manufacturing Practices (GMP) guidelines for herbal medicines
- WHO Guidelines on Traditional Medicine Usage
Correct Answer: WHO Good Manufacturing Practices (GMP) guidelines for herbal medicines
Q3. What is the main aim of WHO Good Agricultural and Collection Practices (GACP) for medicinal plants?
- To accelerate commercialization of all wild plants
- To ensure quality and safety of raw herbal materials through proper cultivation and collection
- To prohibit collection of medicinal plants from wild sources
- To standardize packaging formats for herbal products
Correct Answer: To ensure quality and safety of raw herbal materials through proper cultivation and collection
Q4. Which combination of tests is recommended by WHO for reliable botanical identification of raw herbal material?
- Only macroscopic description
- Macroscopic, microscopic, chemical and DNA-based tests
- Only DNA barcoding
- Only chemical assay of a single marker
Correct Answer: Macroscopic, microscopic, chemical and DNA-based tests
Q5. Which analytical approach is commonly recommended by WHO for producing chemical fingerprints of herbal materials?
- Colorimetric pH paper testing
- Chromatographic fingerprinting (HPTLC/HPLC)
- Visual comparison with herbarium sheets only
- Thin-layer paper chromatography without standards
Correct Answer: Chromatographic fingerprinting (HPTLC/HPLC)
Q6. According to WHO guidance, how should marker compounds be selected for standardization of herbal preparations?
- Select the most expensive compound available
- Select compounds unrelated to activity but easy to measure
- Select markers related to known therapeutic activity, stability and abundance
- Choose markers solely based on color properties
Correct Answer: Select markers related to known therapeutic activity, stability and abundance
Q7. Which contaminants and residues does WHO explicitly recommend testing for in herbal drugs?
- Only microbial contamination
- Heavy metals, pesticides, mycotoxins, microbial contaminants and residual solvents
- Only residual solvents and color additives
- Only radionuclide contamination
Correct Answer: Heavy metals, pesticides, mycotoxins, microbial contaminants and residual solvents
Q8. What is the principal purpose of a herbal monograph as encouraged by WHO?
- To provide marketing claims for manufacturers
- To describe culinary uses of the herb
- To provide specifications for identity, purity, assay and test procedures
- To set retail prices for herbal materials
Correct Answer: To provide specifications for identity, purity, assay and test procedures
Q9. Which sampling principle is emphasized by WHO for testing bulk herbal consignments?
- Non-representative sampling from a single batch corner
- Representative and randomized sampling with documented procedures and adequate sample size
- Sampling only after processing into finished product
- Sampling only using visual inspection
Correct Answer: Representative and randomized sampling with documented procedures and adequate sample size
Q10. What role does DNA barcoding play in WHO-recommended quality assessment?
- It replaces all chemical assays
- It helps authenticate botanical species and detect adulteration or substitution
- It measures active compound concentration
- It assesses pesticide residues
Correct Answer: It helps authenticate botanical species and detect adulteration or substitution
Q11. Why does WHO recommend stability testing for herbal medicinal products?
- To enhance color and aroma for marketing
- To determine shelf life, degradation pathways and appropriate storage conditions
- To increase potency beyond labeled content
- To eliminate need for expiry dating
Correct Answer: To determine shelf life, degradation pathways and appropriate storage conditions
Q12. What is the role of certified reference materials in WHO quality assessment practices?
- Replace the need for analytical instruments
- They are used for assay calibration, method validation and ensuring traceability of results
- Serve as packaging materials
- Used only for marketing claims
Correct Answer: They are used for assay calibration, method validation and ensuring traceability of results
Q13. How should microbial limits for herbal products be set according to WHO principles?
- Microbial limits are irrelevant for herbal products
- Set limits based on product type, route of administration and intended use, aligning with pharmacopeial or WHO guidance
- Allow any microbial counts if herbs are dried
- Use only visual inspection to assess microbial quality
Correct Answer: Set limits based on product type, route of administration and intended use, aligning with pharmacopeial or WHO guidance
Q14. Which combined approach is most effective for detecting adulteration in herbal samples per WHO recommendations?
- Only organoleptic testing
- Chemical analysis, DNA authentication and microscopic examination together
- Only measuring moisture content
- Only GC-MS screening for essential oils
Correct Answer: Chemical analysis, DNA authentication and microscopic examination together
Q15. Which element is a core component of WHO-recommended quality assurance for herbal medicines?
- Ignoring documentation to speed up release
- Comprehensive documentation, traceability and well-defined QA/QC procedures
- Relying solely on supplier reputation without testing
- Eliminating stability testing to reduce costs
Correct Answer: Comprehensive documentation, traceability and well-defined QA/QC procedures
Q16. Which WHO publication specifically focuses on contaminants and residues in herbal medicines?
- WHO Guidelines on Pharmacovigilance
- WHO Guidelines for assessing quality of herbal medicines with reference to contaminants and residues
- WHO Manual on Herbal Marketing
- WHO Traditional Medicine Compilation for Culinary Herbs
Correct Answer: WHO Guidelines for assessing quality of herbal medicines with reference to contaminants and residues
Q17. Under WHO guidance, when is raw botanical material considered adulterated?
- If it contains the expected species and parts with proper documentation
- If it is intentionally substituted or mixed with other species or contains undeclared synthetic drugs
- If it is dried instead of fresh
- If it has natural variation in active constituents
Correct Answer: If it is intentionally substituted or mixed with other species or contains undeclared synthetic drugs
Q18. What is the purpose of using a stability-indicating analytical method in herbal product testing?
- To only quantify solvents without degradation detection
- To detect and quantify the active marker and its degradation products under stress conditions
- To replace identity testing entirely
- To measure only color changes during storage
Correct Answer: To detect and quantify the active marker and its degradation products under stress conditions
Q19. According to WHO guidance, which storage conditions are generally recommended for preserving herbal material quality?
- Warm, humid and exposed to sunlight
- Cool, dry, well-ventilated and protected from light with documented conditions
- Freezing at -80°C for all herbal raw materials
- Storage without any packaging to allow airflow
Correct Answer: Cool, dry, well-ventilated and protected from light with documented conditions
Q20. Why is maintaining a documented chain of custody important for herbal raw materials under WHO guidelines?
- To increase retail prices
- To ensure traceability, accountability and enable recall or investigation if quality issues arise
- To allow anonymous sourcing without records
- To speed up shipment by skipping inspections
Correct Answer: To ensure traceability, accountability and enable recall or investigation if quality issues arise
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