Formulation and production management of herbal products MCQs With Answer

Introduction: This quiz collection focuses on “Formulation and Production Management of Herbal Products” tailored for M.Pharm students studying Industrial Pharmacognostical Technology (MPG 104T). It covers critical areas such as standardization, extraction techniques, GMP and regulatory requirements, scale-up challenges, dosage form design, stability, and quality control specific to herbal matrices. Questions are designed to test conceptual understanding and practical decision-making used in industry—material selection, process optimization, validation, and documentation. Use these MCQs to reinforce classroom learning, prepare for university exams, and sharpen skills for research or manufacturing roles involving the development and quality-assured production of herbal pharmaceuticals.

Q1. What is the primary objective of formulation and production management for herbal products?

• Maximize extraction yield irrespective of quality
• Ensure consistent quality, safety and therapeutic efficacy of herbal products
• Minimize raw material costs only
• Eliminate all variability by chemical synthesis of actives

Correct Answer: Ensure consistent quality, safety and therapeutic efficacy of herbal products

Q2. Which factor is the greatest challenge in standardizing herbal drug preparations?

• Complex chemical variability due to multiple bioactive constituents
• Availability of monochrome packaging materials
• Overabundance of single-marker assays
• Excessive thermal stability of all constituents

Correct Answer: Complex chemical variability due to multiple bioactive constituents

Q3. For extraction of thermolabile and volatile constituents from an herb, which technique is preferred?

• Soxhlet extraction
• Maceration (cold extraction)
• Reflux extraction at high temperature
• Strong alkaline hydrolysis

Correct Answer: Maceration (cold extraction)

Q4. What is the principal role of functional excipients in herbal tablet formulations?

• Act solely as diluents without affecting release
• Facilitate processing, improve stability and enhance patient acceptability
• React chemically with active constituents to form new entities
• Serve only as preservatives to extend shelf-life

Correct Answer: Facilitate processing, improve stability and enhance patient acceptability

Q5. Which analytical approach provides a comprehensive chemical fingerprint for herbal standardization?

• Loss on drying
• High-Performance Thin-Layer Chromatography (HPTLC) fingerprinting
• Bulk density measurement
• pH measurement only

Correct Answer: High-Performance Thin-Layer Chromatography (HPTLC) fingerprinting

Q6. What does Drug:Extract Ratio (DER) indicate in herbal extract specifications?

• The percentage of water in the extract
• The weight relationship of starting herbal drug to the final extract
• The shelf-life of the extract at room temperature
• The hardness of compressed herbal tablets

Correct Answer: The weight relationship of starting herbal drug to the final extract

Q7. Which drying method is best suited to produce dry herbal extracts while preserving heat-sensitive phytoconstituents?

• Spray drying at high inlet temperatures
• Freeze drying (lyophilization)
• Open sun drying with direct sunlight
• High-temperature drum drying

Correct Answer: Freeze drying (lyophilization)

Q8. During scale-up of a granulation process for an herbal tablet, which parameter most critically affects tablet content uniformity?

• Color of the granules
• Binder concentration and mixing uniformity
• Packaging label design
• Tablet punch diameter alone

Correct Answer: Binder concentration and mixing uniformity

Q9. According to good manufacturing practices for herbal products, which of the following is essential documentation?

• Only supplier invoices
• Complete batch manufacturing records and standard operating procedures (SOPs)
• Employee vacation schedules exclusively
• Sales projections for the next five years

Correct Answer: Complete batch manufacturing records and standard operating procedures (SOPs)

Q10. Which preservative strategy is preferable for water-containing herbal formulations to control microbial growth without compromising actives?

• Add strong oxidizing agents indiscriminately
• Use a validated preservative system compatible with herbal constituents
• Rely solely on high sugar content
• Exclude preservatives and depend only on glass packaging

Correct Answer: Use a validated preservative system compatible with herbal constituents

Q11. Which parameter is most informative for assessing inorganic contamination in crude herbal drug material?

• Total ash and acid-insoluble ash values
• Optical rotation alone
• HPLC retention time of marker compound
• pH of an aqueous extract only

Correct Answer: Total ash and acid-insoluble ash values

Q12. For controlling pesticide residues in herbal raw materials, which approach is part of production management?

• Ignoring suppliers and sourcing randomly
• Implementing supplier qualification, incoming raw material testing and adherence to MRL limits
• Assuming traditional use guarantees absence of residues
• Relying only on visual inspection of plant material

Correct Answer: Implementing supplier qualification, incoming raw material testing and adherence to MRL limits

Q13. Which stability study condition is most appropriate to establish accelerated shelf-life for an herbal capsule?

• Storage at 4°C and 40% RH for one month
• 40°C ± 2°C and 75% ± 5% relative humidity for six months
• Direct sunlight exposure for two hours
• Storage in a vacuum for 24 hours

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

Q14. Which regulatory guideline is most relevant for quality control of traditional herbal medicinal products?

• ICH Q1A only
• WHO guidelines on Good Agricultural and Collection Practices (GACP) and GMP for herbal products
• Pharmacopoeial monographs are irrelevant
• ISO 9000 exclusively for marketing

Correct Answer: WHO guidelines on Good Agricultural and Collection Practices (GACP) and GMP for herbal products

Q15. What is the main advantage of using standardized extracts rather than crude powdered herb in dosage forms?

• Standardized extracts provide reproducible concentrations of defined marker compounds, improving dose consistency
• Crude powders are always more stable
• Extracts eliminate the need for quality control
• Crude powders guarantee better bioavailability

Correct Answer: Standardized extracts provide reproducible concentrations of defined marker compounds, improving dose consistency

Q16. Which in-process control is critical during preparation of an herbal ointment to ensure homogeneity?

• Monitoring melting point of the base only
• Viscosity measurement and content uniformity checks
• Checking the color under UV light only
• Measuring the pH of the solid base

Correct Answer: Viscosity measurement and content uniformity checks

Q17. What is the role of marker compounds in herbal product quality control?

• They are cosmetic additives only
• They serve as reference analytes for identification, quantification and batch-to-batch consistency
• They replace microbiological testing completely
• They always indicate potency regardless of extraction method

Correct Answer: They serve as reference analytes for identification, quantification and batch-to-batch consistency

Q18. Which manufacturing validation is most important when introducing a new solvent-based extraction at commercial scale?

• Operator training records only
• Process validation including solvent recovery efficiency, reproducibility, and residual solvent limits
• Marketing authorization before process validation
• Only sensory evaluation of extract color

Correct Answer: Process validation including solvent recovery efficiency, reproducibility, and residual solvent limits

Q19. In herbal capsule formulation, which approach helps to mask unpleasant taste while maintaining release profile?

• Using taste-masking granules or enteric/coating technologies
• Reducing active dose arbitrarily
• Adding sugar crystals to the fill material
• Leaving capsules open to air

Correct Answer: Using taste-masking granules or enteric/coating technologies

Q20. Which microbiological specification is generally critical for non-sterile oral herbal products?

• Total viable aerobic microbial count and absence of specified pathogens (e.g., E. coli, Salmonella)
• Presence of any fungal species is acceptable
• Only latent virus testing is required
• No microbiological testing is necessary for traditional herbs

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

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