Herbal drug standardization – WHO guidelines MCQs With Answer

Introduction: Herbal drug standardization – WHO guidelines MCQs With Answer is a focused quiz resource tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). This set emphasizes the World Health Organization’s approaches to quality assurance, safety, and efficacy of herbal medicines, covering concepts such as Good Agricultural and Collection Practices (GACP), identity, purity, potency, marker compounds, analytical fingerprinting, and safety testing. Questions are designed to deepen understanding of WHO-recommended procedures, pharmacopoeial monographs, analytical techniques (HPLC, HPTLC, GC-MS), and regulatory requirements for herbal product development and batch release. Use these MCQs for revision, self-assessment, and exam preparation.

Q1. According to WHO guidelines, which primary step is essential before establishing specifications for a herbal drug?

• Conducting a full clinical trial on humans
• Documenting botanical identity and traditional use
• Manufacturing pilot batches in industrial scale
• Performing stability studies for five years

Correct Answer: Documenting botanical identity and traditional use

Q2. Which WHO recommendation specifically addresses the cultivation and collection of medicinal plants to ensure quality?

• Good Manufacturing Practice (GMP)
• Good Agricultural and Collection Practices (GACP)
• Good Clinical Practice (GCP)
• Good Distribution Practice (GDP)

Correct Answer: Good Agricultural and Collection Practices (GACP)

Q3. In WHO monograph preparation for herbal drugs, which parameter is NOT typically included in the specification?

• Botanical identification (macroscopy/microscopy)
• Quantitative assay for marker constituents
• Clinical therapeutic guidelines for dosing
• Limits for contaminants (heavy metals, pesticides)

Correct Answer: Clinical therapeutic guidelines for dosing

Q4. Which analytical approach does WHO emphasize for establishing chemical fingerprint profiles of complex herbal materials?

• Organoleptic testing only
• Tissue culture analysis
• Chromatographic fingerprinting (HPTLC/HPLC/GC)
• Simple UV-visible spectrophotometry without separation

Correct Answer: Chromatographic fingerprinting (HPTLC/HPLC/GC)

Q5. WHO recommends DNA-based methods primarily for which aspect of herbal drug standardization?

• Quantitative assay of active marker compounds
• Determination of residual solvent limits
• Authentication and detection of adulteration/contamination
• Assessing extract stability under accelerated conditions

Correct Answer: Authentication and detection of adulteration/contamination

Q6. For herbal extracts, WHO suggests selection of marker compounds for standardization. Which statement best describes a marker compound?

• An inactive compound unrelated to therapeutic effect
• A constituent used exclusively for flavoring
• A chemical constituent indicative of identity, quality or potency
• A compound chosen for regulatory convenience only

Correct Answer: A chemical constituent indicative of identity, quality or potency

Q7. Which test is a WHO-recommended limit test for assessing elemental contaminants in herbal materials?

• TLC fingerprinting
• Atomic Absorption Spectroscopy (AAS) or ICP-MS
• Loss on drying
• Thin-layer silica screening

Correct Answer: Atomic Absorption Spectroscopy (AAS) or ICP-MS

Q8. According to WHO, which microbiological parameter is critical for herbal products intended for oral consumption?

• Total aerobic microbial count and absence of specified pathogens (e.g., Salmonella, E. coli)
• Only fungal contamination testing is required
• Testing for viral contaminants is sufficient
• No microbiological testing required for dried plant materials

Correct Answer: Total aerobic microbial count and absence of specified pathogens (e.g., Salmonella, E. coli)

Q9. What is the primary purpose of stability testing as per WHO guidelines for herbal finished products?

• To identify pharmacological mechanisms of action
• To establish shelf life and recommended storage conditions
• To maximize extraction yield during manufacturing
• To validate clinical efficacy endpoints

Correct Answer: To establish shelf life and recommended storage conditions

Q10. Which of the following is a WHO-recommended approach to ensure consistent potency between herbal product batches?

• Relying only on visual inspection of raw materials
• Assaying for defined marker constituents and applying blending control
• Using random suppliers without documentation
• Eliminating all quality control tests to reduce cost

Correct Answer: Assaying for defined marker constituents and applying blending control

Q11. WHO emphasizes documentation of traceability from plant material to finished product. Which document is essential for batch traceability?

• Master formula/Batch manufacturing record
• Generic advertising brochure
• Clinical trial informed consent form
• Company vision statement

Correct Answer: Master formula/Batch manufacturing record

Q12. In the WHO quality control framework, what is the role of a pharmacopoeial monograph for a herbal drug?

• To describe only traditional uses without analytical tests
• To provide standardized identity, purity, assay, and test methods for quality control
• To replace all local regulatory requirements automatically
• To provide clinical dosing regimens for all populations

Correct Answer: To provide standardized identity, purity, assay, and test methods for quality control

Q13. Which of the following is considered a critical impurity to test for in WHO guidelines when standardizing herbal extracts?

• Sugar content of the formulation
• Pesticide residues and heavy metals
• Color of the final product
• Brand logo consistency

Correct Answer: Pesticide residues and heavy metals

Q14. According to WHO, what is the recommended strategy when no single chemical marker fully represents the therapeutic activity of an herb?

• Ignore marker-based standardization entirely
• Use multiple marker compounds and fingerprinting approaches
• Standardize only on crude extract weight
• Adopt a fixed dosage without assays

Correct Answer: Use multiple marker compounds and fingerprinting approaches

Q15. Which validation parameter is most relevant when developing an HPLC assay for an herbal marker according to WHO/ICH guidance?

• Tint test
• Specificity, accuracy, precision, linearity, and robustness
• Only specificity is necessary
• Employee preference survey

Correct Answer: Specificity, accuracy, precision, linearity, and robustness

Q16. WHO guidance for traditional herbal medicines recommends which action regarding traditional knowledge and safety data?

• Disregard traditional use, rely solely on modern clinical trials
• Document traditional use and compile available safety/toxicity information to inform risk assessment
• Replace traditional knowledge with synthetic analogues
• Assume traditional use guarantees safety without documentation

Correct Answer: Document traditional use and compile available safety/toxicity information to inform risk assessment

Q17. For herbal products, which residual solvent class is considered the most hazardous and tightly controlled under WHO-compatible guidelines?

• Class 3 solvents (low toxic potential)
• Class 1 solvents (known human carcinogens and strongly restricted)
• Water used in extraction
• Natural essential oils

Correct Answer: Class 1 solvents (known human carcinogens and strongly restricted)

Q18. WHO suggests inclusion of which information in a herbal product specification to control variability from the plant source?

• Harvesting season, plant part, geographical origin and drying conditions
• Only the final tablet color
• Marketing claims about efficacy
• Retail pricing strategy

Correct Answer: Harvesting season, plant part, geographical origin and drying conditions

Q19. Which WHO-endorsed analytical technique is most suitable for volatile constituents standardization in aromatic herbal materials?

• HPLC with UV detection
• Gas Chromatography–Mass Spectrometry (GC-MS)
• Melting point determination
• Optical rotation measurement only

Correct Answer: Gas Chromatography–Mass Spectrometry (GC-MS)

Q20. When a herbal product contains several actives, WHO encourages establishing release criteria based on which combination?

• Only organoleptic properties and color
• Assay of key marker(s), fingerprint similarity, and limits for impurities/contaminants
• Random visual inspection without tests
• Marketing approval without quality testing

Correct Answer: Assay of key marker(s), fingerprint similarity, and limits for impurities/contaminants

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