The World Health Organization (WHO) and International Council for Harmonisation (ICH) guidelines provide essential frameworks for the evaluation of herbal drugs, focusing on quality, safety, and efficacy. B. Pharm students must master concepts such as standardization, phytochemical profiling, authentication, Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP), stability testing, analytical method validation (ICH Q2), and specification setting. Key topics include monographs, marker compounds, fingerprinting techniques (HPTLC/HPLC), contaminants (heavy metals, pesticides, aflatoxins), residual solvents, and pharmacovigilance. Understanding these guidelines ensures compliant development, reliable quality control, and patient safety in herbal medicine practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which WHO document primarily guides cultivation and harvesting practices of medicinal plants?
- WHO Monographs on Selected Medicinal Plants
- WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
- WHO Guidelines on Stability Testing of Pharmaceuticals
- WHO Pharmacovigilance Guidelines
Correct Answer: WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
Q2. Which ICH guideline is most directly concerned with validation of analytical procedures used for herbal drug testing?
- ICH Q1A(R2) Stability Testing
- ICH Q2(R1) Validation of Analytical Procedures
- ICH Q3C Residual Solvents
- ICH Q9 Quality Risk Management
Correct Answer: ICH Q2(R1) Validation of Analytical Procedures
Q3. In herbal drug standardization, what does “fingerprinting” usually refer to?
- Recording the GPS location of plant collection
- Comprehensive chemical profile using chromatographic/spectroscopic methods
- Measuring microbial load only
- Assessing packaging integrity
Correct Answer: Comprehensive chemical profile using chromatographic/spectroscopic methods
Q4. Which parameter is NOT one of the typical validation characteristics listed in ICH Q2 for an analytical method?
- Specificity
- Linearity
- Accuracy
- Monograph authorship
Correct Answer: Monograph authorship
Q5. Which WHO guideline helps laboratories set microbial limits for herbal products?
- WHO Guidelines on Quality Control Methods for Medicinal Plant Materials
- WHO Good Distribution Practices
- WHO Vaccine Storage Manual
- WHO Traditional Medicine Strategy (only policy)
Correct Answer: WHO Guidelines on Quality Control Methods for Medicinal Plant Materials
Q6. According to ICH Q1A, which factor is critical when designing stability studies for herbal dosage forms?
- Selection of chromatographic brand
- Choice of storage conditions and timepoints representative of intended shelf life
- Number of excipients listed alphabetically
- Only in-use stability at extreme temperatures
Correct Answer: Choice of storage conditions and timepoints representative of intended shelf life
Q7. Which analytical technique is commonly recommended by WHO for profiling multiple phytoconstituents in a herbal extract?
- High-performance liquid chromatography (HPLC)
- Atomic absorption spectroscopy for heavy metals only
- Simple color observation of extract
- pH paper strip measurement
Correct Answer: High-performance liquid chromatography (HPLC)
Q8. What is the role of marker compounds in herbal drug standardization?
- They determine the plant’s botanical family only
- Serve as reference constituents to assess identity, potency, and consistency
- Are used to measure moisture content exclusively
- Replace need for microbial testing
Correct Answer: Serve as reference constituents to assess identity, potency, and consistency
Q9. Which contaminant class is specifically covered under ICH Q3C guidelines relevant to herbal products?
- Pesticide residues
- Residual solvents
- Aflatoxins
- Microbial endotoxins
Correct Answer: Residual solvents
Q10. For herbal products, DNA barcoding is mainly used to:
- Test for residual solvents
- Authenticate botanical identity and detect adulteration
- Quantify active marker concentration
- Measure shelf-life under accelerated conditions
Correct Answer: Authenticate botanical identity and detect adulteration
Q11. Which WHO publication provides monograph-style information on single medicinal plants including identification and quality control tests?
- WHO Assessment of Vaccines Manual
- WHO Monographs on Selected Medicinal Plants
- ICH Q2(R1) Guideline
- Pharmacopoeial General Notices only
Correct Answer: WHO Monographs on Selected Medicinal Plants
Q12. In method validation, the limit of detection (LOD) is best defined as:
- The highest concentration that can be measured with accuracy
- The smallest amount of analyte that can be reliably distinguished from background noise
- The time needed to complete analysis
- The required sample size for clinical trials
Correct Answer: The smallest amount of analyte that can be reliably distinguished from background noise
Q13. Which WHO/ICH principle supports setting specification limits for herbal drug batches?
- Quality by design (QbD) and predefined acceptance criteria based on safety and clinical relevance
- Random acceptance without testing
- Only color and odor assessment
- Manufacturer’s marketing claims alone
Correct Answer: Quality by design (QbD) and predefined acceptance criteria based on safety and clinical relevance
Q14. Which test is essential to evaluate potential hepatotoxic contaminants like aflatoxins in herbal products?
- HPLC with fluorescence detection or LC-MS after appropriate cleanup
- Simple boiling test
- GC headspace for residual solvents only
- pH meter testing
Correct Answer: HPLC with fluorescence detection or LC-MS after appropriate cleanup
Q15. What does GACP stand for and why is it important?
- Good Analytical and Cleaning Procedures; for lab hygiene
- Good Agricultural and Collection Practices; to ensure raw material quality, traceability and minimize contamination
- General Approved Chemical Procedures; for reagent handling
- Good Accreditation for Clinical Practices; for clinical trials only
Correct Answer: Good Agricultural and Collection Practices; to ensure raw material quality, traceability and minimize contamination
Q16. Which parameter assesses the ability of an analytical method to measure the analyte in presence of other components (excipients, matrix) in herbal formulations?
- Precision
- Specificity (or selectivity)
- Robustness
- Linearity
Correct Answer: Specificity (or selectivity)
Q17. What is a stability-indicating method?
- An assay that measures potency only at time zero
- A validated method that accurately quantifies the active(s) in presence of degradation products
- A visual check for tablet cracking
- A method for counting microbial colonies only
Correct Answer: A validated method that accurately quantifies the active(s) in presence of degradation products
Q18. Which WHO recommendation improves reproducibility of herbal material identity in pharmacognostic evaluation?
- Use of local common names only
- Detailed macroscopic and microscopic characterization plus voucher specimen deposition
- Packaging the material in colored bags
- Omitting botanical nomenclature
Correct Answer: Detailed macroscopic and microscopic characterization plus voucher specimen deposition
Q19. Which parameter is most relevant when deciding accelerated stability study conditions per ICH Q1A for a herbal product intended for use in a hot, humid climate?
- Storage at 25°C/60% RH only
- Use of climate zone-specific accelerated conditions such as 40°C/75% RH
- Only refrigerated conditions
- Testing at 0°C for freeze effects only
Correct Answer: Use of climate zone-specific accelerated conditions such as 40°C/75% RH
Q20. What is the primary concern addressed by pharmacovigilance for herbal medicines?
- Only marketing claims
- Detection, assessment and prevention of adverse reactions and interactions
- Increasing sales volume
- Packaging aesthetics
Correct Answer: Detection, assessment and prevention of adverse reactions and interactions
Q21. When setting a specification for residual pesticides in herbal raw material, which guidance is most appropriate?
- WHO or regional pharmacopoeial limits and national pesticide residue regulations
- Manufacturer’s preferred safety margin only
- Assume zero pesticide without testing
- Use ICH Q2 for pesticide limits directly
Correct Answer: WHO or regional pharmacopoeial limits and national pesticide residue regulations
Q22. Which analytical approach is most suitable for simultaneous quantification of several volatile phytoconstituents?
- GC-MS
- HPTLC for volatiles only
- Microscopy
- UV-visible color comparison
Correct Answer: GC-MS
Q23. What is the main objective of establishing a herbal product monograph?
- Provide marketing slogans
- Define identity, purity, strength, and recommended analytical tests and limits for quality control
- Limit clinical trial enrollment
- Describe pharmacoeconomic strategies only
Correct Answer: Define identity, purity, strength, and recommended analytical tests and limits for quality control
Q24. In herbal drug evaluation, “adulteration” most commonly means:
- Intentional or unintentional substitution or addition of inferior or different plant material or synthetic drugs
- Proper labeling of botanical origin
- Standardized extraction processes
- Using advanced analytical methods
Correct Answer: Intentional or unintentional substitution or addition of inferior or different plant material or synthetic drugs
Q25. Which ICH guideline provides a framework for assessing impurities including genotoxic impurities relevant to herbal products?
- ICH M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities
- ICH Q2 for dissolution only
- WHO GACP for cultivation
- ICH Q8 Pharmaceutical Development
Correct Answer: ICH M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Q26. Which is the best initial test to discriminate between two closely related plant species in a powdered herbal sample?
- Macroscopic observation only
- DNA barcoding or PCR-based molecular identification
- Residual solvent analysis
- Accelerated stability testing
Correct Answer: DNA barcoding or PCR-based molecular identification
Q27. Which practice is essential in GMP for herbal manufacturing to ensure batch-to-batch consistency?
- Random changes in formulation
- Comprehensive documentation, batch records, and in-process controls
- Eliminating raw material testing to save time
- Only final visual inspection
Correct Answer: Comprehensive documentation, batch records, and in-process controls
Q28. Which test helps determine moisture-related degradation risk in dried herbal raw materials?
- Loss on drying or Karl Fischer titration to measure moisture content
- HPLC fingerprint only
- DNA sequencing
- pH testing of finished product only
Correct Answer: Loss on drying or Karl Fischer titration to measure moisture content
Q29. Which is a typical acceptance criterion for herbal product identity testing?
- Presence of specified marker peaks or characteristic chromatographic profile matching reference standard
- No testing if raw material looks similar
- Only measuring tablet hardness
- Checking for pleasant smell only
Correct Answer: Presence of specified marker peaks or characteristic chromatographic profile matching reference standard
Q30. Which documentation is critical to support regulatory submissions for herbal drug quality per WHO/ICH expectations?
- Complete dossier including botanical identification, manufacturing process, quality control methods, validation data, stability studies, and safety information
- Only marketing brochures and pictures
- Unsigned handwritten notes without validation
- Commercial pricing strategy
Correct Answer: Complete dossier including botanical identification, manufacturing process, quality control methods, validation data, stability studies, and safety information
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com