Validation of herbal therapies MCQs With Answer

Introduction:

This question bank on Validation of Herbal Therapies is tailored for M.Pharm students preparing for advanced coursework and examinations in Herbal and Cosmetic Analysis (MPA 204T). It focuses on practical and regulatory aspects of validating herbal products and methods — including analytical method validation, standardization of botanicals, stability and process validation, bioassays, safety assessment, and clinical evidence requirements. Questions emphasize internationally accepted guidelines (ICH, WHO), modern techniques (HPTLC, HPLC, GC-MS, chemometrics), and quality systems (GMP, SOPs, AQbD). Use these MCQs to test conceptual depth, interpretative skills, and application of validation principles to real-world herbal product development and quality control.

Q1. Which set of parameters best represents the primary analytical method validation characteristics required by ICH Q2(R1) for herbal marker quantification?

• Specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ)
• Robustness, dissolution, sterility, endotoxin, bioavailability
• Batch size, SOP adherence, packaging, labeling
• Clinical efficacy, adverse events, pharmacovigilance, cost-effectiveness

Correct Answer: Specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ)

Q2. For a chromatographic fingerprint used in herbal standardization, which approach most strengthens batch-to-batch consistency assessment?

• Quantitative marker-only assay without profile comparison
• Comparison of full chromatographic fingerprints with chemometric pattern recognition
• Visual inspection of color and odor by technicians
• Single-point UV absorbance measurement at arbitrary wavelength

Correct Answer: Comparison of full chromatographic fingerprints with chemometric pattern recognition

Q3. Which validation study is essential to demonstrate that an extraction process consistently yields expected phytochemical marker content?

• Analytical method transfer
• Process validation with defined critical process parameters and acceptance criteria
• Accelerated stability testing of finished product only
• Clinical phase III randomized trial

Correct Answer: Process validation with defined critical process parameters and acceptance criteria

Q4. In bioassay validation for herbal pharmacological activity, which characteristic ensures the assay reliably measures the intended biological effect?

• Specificity to the biological mechanism, reproducibility, and defined controls
• Large sample container volume and prolonged incubation only
• Single replicate per batch to reduce cost
• Reliance on historical literature without internal controls

Correct Answer: Specificity to the biological mechanism, reproducibility, and defined controls

Q5. Which guideline is most directly relevant for setting permissible limits for residual solvents in herbal preparations?

• ICH Q3C (Residual Solvents)
• ICH Q6A (Specifications)
• WHO GMP for Herbal Medicines (2011)
• ICH Q9 (Quality Risk Management)

Correct Answer: ICH Q3C (Residual Solvents)

Q6. During method robustness testing for an HPLC assay of a herbal marker, which change would typically be evaluated?

• Deliberate small changes in mobile phase composition, column temperature, and flow rate
• Changing the herbal species used in production
• Switching from HPLC to unrelated microbiological assay
• Altering the clinical study protocol

Correct Answer: Deliberate small changes in mobile phase composition, column temperature, and flow rate

Q7. Which analytical strategy most appropriately addresses the complexity of multi-component herbal formulations for quality control?

• Multi-marker quantification combined with chromatographic fingerprinting and chemometrics
• Single-marker quantification assuming it represents all activity
• Only organoleptic tests (taste, color, smell)
• Exclusive use of animal-based bioassays without chemical profiling

Correct Answer: Multi-marker quantification combined with chromatographic fingerprinting and chemometrics

Q8. For establishing a stability-indicating method for a herbal extract, what is required?

• Ability to separate degradation products from the active markers and demonstrate specificity
• Only initial assay without forced degradation
• Use of non-specific colorimetric reagents
• Monitoring of packaging aesthetics alone

Correct Answer: Ability to separate degradation products from the active markers and demonstrate specificity

Q9. In clinical validation of an herbal therapy, which trial phase primarily assesses efficacy and dose-response in target patients?

• Phase II randomized controlled trials
• Phase I healthy volunteer single-dose studies
• Phase IV post-marketing surveillance
• Preclinical in vitro assays

Correct Answer: Phase II randomized controlled trials

Q10. Which parameter is most important when selecting a chemical marker for standardization of an herbal drug?

• Specificity to the species and correlation with therapeutic activity or safety profile
• Having the highest concentration irrespective of relevance
• Being expensive to assay to ensure premium pricing
• Ease of evaporation during drying

Correct Answer: Specificity to the species and correlation with therapeutic activity or safety profile

Q11. Which quality attribute is addressed by microbial limit testing in herbal product validation?

• Bioburden control and absence of specific pathogens to ensure safety and stability
• Quantitation of phytochemical markers only
• Determination of heavy metal speciation
• Measurement of particle size distribution

Correct Answer: Bioburden control and absence of specific pathogens to ensure safety and stability

Q12. What is the principal objective of Analytical Quality by Design (AQbD) in method development for herbal assays?

• To understand method variables, define a design space, and ensure method robustness and lifecycle control
• To eliminate method validation altogether
• To prioritize marketing claims over scientific data
• To reduce sample throughput and increase manual steps

Correct Answer: To understand method variables, define a design space, and ensure method robustness and lifecycle control

Q13. Which toxicological assessment is essential for a new herbal extract before human trials?

• GLP-compliant acute and subchronic toxicity studies, genotoxicity, and safety pharmacology as appropriate
• Only traditional-use literature citation without animal studies
• Phase III clinical trial directly in patients
• Shelf-life testing of final product packaging

Correct Answer: GLP-compliant acute and subchronic toxicity studies, genotoxicity, and safety pharmacology as appropriate

Q14. During method transfer between laboratories, which documentation is critical to demonstrate successful transfer for a validated herbal assay?

• Comparative validation results, system suitability data, SOPs, and analyst training records
• Only a faxed copy of the certificate of analysis from the originator
• Marketing brochures and sales figures
• Unsupervised verbal agreement between lab managers

Correct Answer: Comparative validation results, system suitability data, SOPs, and analyst training records

Q15. For heavy metal limits in herbal products, which organization provides widely accepted permissible limits and testing guidance?

• WHO guidelines for assessing quality of herbal medicines
• Clinical trial registries
• Local advertising standards authority
• Food delivery services

Correct Answer: WHO guidelines for assessing quality of herbal medicines

Q16. Which validation concept ensures that process changes do not adversely affect the quality of a botanical product?

• Comparability and bridging studies demonstrating equivalence across processes
• Marketing-driven reformulation without testing
• Ignoring critical process parameters once initial batches pass QC
• Relying solely on finished-product organoleptic testing

Correct Answer: Comparability and bridging studies demonstrating equivalence across processes

Q17. In stability studies for herbal products, which storage condition is typically used for accelerated testing?

• 40°C ± 2°C and 75% ± 5% relative humidity
• 0°C under vacuum with no humidity control
• Room temperature for one day only
• Complete darkness at arbitrary temperature

Correct Answer: 40°C ± 2°C and 75% ± 5% relative humidity

Q18. What is the role of reference standards in herbal assay validation?

• Provide identity, purity, and response calibration for marker quantification and system suitability
• Used only for labeling design inspiration
• Replace the need for method precision studies
• Serve as packaging materials

Correct Answer: Provide identity, purity, and response calibration for marker quantification and system suitability

Q19. Which post-marketing activity is specific to herbal therapies to monitor long-term safety in populations?

• Phytovigilance: active surveillance of adverse events, herb-drug interactions, and batch quality issues
• Monthly chromatographic fingerprinting of every sold unit
• Annual advertisement audits
• Exclusive reliance on preclinical toxicity data

Correct Answer: Phytovigilance: active surveillance of adverse events, herb-drug interactions, and batch quality issues

Q20. Which combination best describes a stability-indicating analytical method for an herbal marker?

• Specificity to marker, separation from degradants, validated accuracy and precision across the stability range
• Only rapid throughput with no forced degradation studies
• Colorimetric total phenolic assay without peak resolution
• Assay dependent solely on olfactory assessment

Correct Answer: Specificity to marker, separation from degradants, validated accuracy and precision across the stability range

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