ICH guidelines for quality control of herbal medicines MCQs With Answer

Introduction: The ICH guidelines for quality control of herbal medicines provide B.Pharm students with a regulatory framework to ensure safety, efficacy and consistent quality of botanical products. These guidance documents—linking pharmacognosy, quality assurance and analytical methods—cover specifications, validation of analytical procedures (ICH Q2), stability testing (ICH Q1), impurities, good manufacturing practices (GMP) and documentation. Understanding ICH principles helps students design robust quality control strategies, implement standardized assays, perform chromatographic and spectroscopic testing, and assess batch-to-batch consistency for herbal extracts and finished products. Mastery of these topics is essential for careers in pharmaceutical industry, regulatory affairs and research. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which ICH guideline primarily addresses validation of analytical procedures used in quality control of herbal medicines?

• ICH Q1
• ICH Q2
• ICH Q3
• ICH Q7

Correct Answer: ICH Q2

Q2. In herbal medicine quality control, which validation parameter assesses the closeness between an experimental value and the true value?

• Precision
• Linearity
• Accuracy
• Robustness

Correct Answer: Accuracy

Q3. Which ICH guideline deals mainly with stability testing of substances and products, applicable to herbal formulations?

• ICH Q1
• ICH Q2
• ICH Q3
• ICH Q9

Correct Answer: ICH Q1

Q4. For herbal extracts, a stability-indicating method must demonstrate which key attribute?

• High throughput
• Specificity to quantify marker in presence of degradation products
• Minimum sample volume
• Non-destructive analysis only

Correct Answer: Specificity to quantify marker in presence of degradation products

Q5. In HPLC method validation for a herbal marker compound, which parameter evaluates repeatability of results under same conditions?

• Intermediate precision
• Accuracy
• System suitability
• Precision (repeatability)

Correct Answer: Precision (repeatability)

Q6. Which ICH document provides principles for pharmaceutical quality system and continuous improvement relevant to herbal product manufacture?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11

Correct Answer: ICH Q10

Q7. When assessing heavy metal contamination in herbal raw materials, which guideline or standard is most commonly referenced for limits?

• ICH Q2
• Pharmacopoeial monographs (e.g., USP, EP)
• ICH Q1
• ICH Q3

Correct Answer: Pharmacopoeial monographs (e.g., USP, EP)

Q8. Which analytical parameter defines the lowest analyte concentration that can be reliably detected but not necessarily quantified?

• Limit of Quantitation (LOQ)
• Limit of Detection (LOD)
• Linearity
• Specificity

Correct Answer: Limit of Detection (LOD)

Q9. For herbal products, chromatographic fingerprinting is primarily used to:

• Determine particle size distribution
• Confirm botanical identity and batch consistency
• Measure moisture content
• Test endotoxin levels

Correct Answer: Confirm botanical identity and batch consistency

Q10. Which ICH guideline focuses on impurities including identification and qualification thresholds that may be applicable to herbal drug substances?

• ICH Q3
• ICH Q1
• ICH Q2
• ICH Q8

Correct Answer: ICH Q3

Q11. In method validation, which test evaluates linearity?

• Plot of response vs concentration and calculation of correlation coefficient
• Repeated analysis of single concentration
• Forced degradation study
• Robustness by changing pH

Correct Answer: Plot of response vs concentration and calculation of correlation coefficient

Q12. What is the main purpose of forced degradation studies for herbal formulations?

• To enhance potency
• To identify degradation pathways and develop stability-indicating methods
• To determine microbial limits
• To measure bulk density

Correct Answer: To identify degradation pathways and develop stability-indicating methods

Q13. Which parameter is NOT typically part of ICH Q2 analytical validation?

• Specificity
• Limit of detection
• Microbial bioburden limits
• Precision

Correct Answer: Microbial bioburden limits

Q14. For herbal tinctures, which test evaluates microbial safety according to quality control practices?

• Loss on drying
• Microbial limit test
• Assay by HPLC only
• Specific rotation

Correct Answer: Microbial limit test

Q15. During chromatographic method validation, system suitability tests commonly include which of the following?

• Resolution, theoretical plates, tailing factor
• Moisture content, ash value
• pH measurement only
• Particle size analysis

Correct Answer: Resolution, theoretical plates, tailing factor

Q16. Which risk management approach from ICH helps prioritize quality control activities for herbal products?

• ICH Q7 GMP checklist
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• ICH Q3 Impurity thresholds

Correct Answer: ICH Q9 Quality Risk Management

Q17. Which solvent-related control is important when preparing herbal extracts and is guided by pharmacopeial or ICH recommendations?

• Residual solvent limits
• Particle size limits
• Heavy metal analysis only
• Viscosity limits

Correct Answer: Residual solvent limits

Q18. Marker-based standardization of a herbal extract aims to:

• Ensure a fixed concentration of a known active or marker compound for batch consistency
• Eliminate need for stability testing
• Replace all QC tests with a single assay
• Standardize taste only

Correct Answer: Ensure a fixed concentration of a known active or marker compound for batch consistency

Q19. Which of the following describes ‘specificity’ in analytical method validation?

• Ability of method to provide precise results under varied conditions
• Ability to assess analyte response linearity
• Ability to measure the analyte unequivocally in presence of other components
• Lowest concentration that can be quantified

Correct Answer: Ability to measure the analyte unequivocally in presence of other components

Q20. Which stability storage condition is commonly used for accelerated stability testing for many products?

• 5°C ±3°C
• 25°C ±2°C/60% RH ±5% RH
• 40°C ±2°C/75% RH ±5% RH
• 0°C ±5°C

Correct Answer: 40°C ±2°C/75% RH ±5% RH

Q21. A validation parameter that measures closeness of individual results to each other under changed conditions (different days, analysts) is called:

• Accuracy
• Repeatability
• Intermediate precision
• Specificity

Correct Answer: Intermediate precision

Q22. In herbal quality control, which test helps detect pesticide residues in raw plant material?

• HPLC-UV for marker
• GC-MS or LC-MS/MS targeted pesticide analysis
• Loss on drying
• Disintegration test

Correct Answer: GC-MS or LC-MS/MS targeted pesticide analysis

Q23. Which documentation is essential for traceability and batch release under GMP for herbal medicines?

• Analytical test records, certificate of analysis, batch manufacturing record
• Only marketing materials
• Student lab notebooks
• Packaging design sketches

Correct Answer: Analytical test records, certificate of analysis, batch manufacturing record

Q24. Which of the following is most suitable to confirm botanical identity of raw herbal material?

• Organoleptic evaluation only
• DNA barcoding combined with macroscopic/microscopic and chemical tests
• Only HPLC fingerprint
• Only moisture testing

Correct Answer: DNA barcoding combined with macroscopic/microscopic and chemical tests

Q25. What does ‘robustness’ of an analytical method evaluate?

• Effect of small deliberate variations in method parameters on results
• Cost effectiveness of the method
• Microbial contamination probability
• Speed of analysis only

Correct Answer: Effect of small deliberate variations in method parameters on results

Q26. For herbal dosage forms, which ICH guidance would help in evaluating changes after regulatory submission?

• ICH Q1
• ICH Q12
• ICH Q2
• ICH Q3

Correct Answer: ICH Q12

Q27. Which impurity type is of special concern in herbal preparations due to botanical origin and may require testing?

• Elemental impurities (heavy metals)
• Monograph-defined tablet disintegrants
• Synthetic process-related by-products only
• Pharmaceutical coating pigments

Correct Answer: Elemental impurities (heavy metals)

Q28. When developing an HPLC assay for a herbal marker, which mobile phase change would be tested under robustness?

• Change in column brand only
• Small variation in mobile phase pH or organic composition
• Elimination of detection wavelength
• Omission of sample preparation entirely

Correct Answer: Small variation in mobile phase pH or organic composition

Q29. Which of the following best describes ‘assay’ in the context of herbal product quality control?

• Measure of microbial contamination
• Quantitative determination of active or marker constituent in a sample
• Visual inspection of packaging
• Measurement of tablet hardness only

Correct Answer: Quantitative determination of active or marker constituent in a sample

Q30. According to quality control principles, why is the use of reference standards important for herbal assays?

• They are decorative and not necessary
• Provide traceable, accurate identification and quantitation of analytes
• Reduce the need for validation
• Replace chromatographic methods

Correct Answer: Provide traceable, accurate identification and quantitation of analytes

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