Herbal drug industry infrastructure and standardized extract production MCQs With Answer

This quiz collection on “Herbal drug industry infrastructure and standardized extract production” is designed for M.Pharm students preparing for Industrial Pharmacognostical Technology (MPG 104T). It focuses on practical and regulatory aspects of building and operating herbal manufacturing facilities, selection and scale-up of extraction technologies, drying and formulation of standardized extracts, and the analytical and quality-control strategies used to ensure identity, purity and potency. Questions emphasize equipment choice, process parameters, standardization approaches, validation, GMP, and contemporary analytical methods (chemical, biological and molecular). Use these MCQs to assess and deepen your understanding of translating herbal raw materials into consistent, regulatory-compliant medicinal extracts.

Q1. What is the primary layout consideration for preventing cross‑contamination in a multi‑product herbal extract manufacturing plant?

• Dedicated segregation of raw material, processing and packaging areas with controlled material and personnel flow
• Minimizing distance between storage and dispatch to reduce transport time
• Locating offices adjacent to production for quick supervision
• Designing the plant for maximum visual appeal

Correct Answer: Dedicated segregation of raw material, processing and packaging areas with controlled material and personnel flow

Q2. Which industrial equipment is most suitable for continuous large‑scale thermal concentration and solvent recovery of herbal liquid extracts?

• Rotary evaporator
• Falling film evaporator
• Freeze dryer (lyophilizer)
• Tray dryer

Correct Answer: Falling film evaporator

Q3. Which standardization approach relies on quantifying one or more chemically defined marker compounds in the extract?

• Chemical standardization
• Biological standardization (bioassay)
• Sensory standardization
• Physical standardization (particle size)

Correct Answer: Chemical standardization

Q4. How is the extract ratio (drug:extract ratio, DER) typically defined in herbal extract production?

• The weight of starting dried plant material to the weight of the final dried extract
• The solvent volume used per batch
• The percentage of active marker in the extract
• The ratio of moisture to ash in the extract

Correct Answer: The weight of starting dried plant material to the weight of the final dried extract

Q5. Which carrier is commonly used to aid spray drying of aqueous herbal extracts and improve powder properties?

• Maltodextrin
• Lactose monohydrate
• Microcrystalline cellulose
• Talc

Correct Answer: Maltodextrin

Q6. Which analytical technique is preferred for determination and quantification of residual organic solvents in herbal extracts according to pharmacopoeial limits?

• Gas chromatography (GC)
• High‑performance liquid chromatography (HPLC)
• Ultraviolet–visible spectrophotometry (UV‑Vis)
• Fourier‑transform infrared spectroscopy (FTIR)

Correct Answer: Gas chromatography (GC)

Q7. Which test panel is essential for microbiological quality assessment of finished herbal extracts per pharmacopeial microbial limits?

• Total aerobic microbial count (TAMC) and total yeast and mold count (TYMC)
• Heavy metals screening by AAS
• Pesticide residue screening by GC‑MS
• Total ash and acid‑insoluble ash

Correct Answer: Total aerobic microbial count (TAMC) and total yeast and mold count (TYMC)

Q8. Which spray drying parameter has the greatest influence on final powder residual moisture and particle morphology?

• Inlet air temperature
• Feed pH
• Finished batch labelling
• Room lighting in the plant

Correct Answer: Inlet air temperature

Q9. When a standardized extract is specified by marker content, which element is critical to include in product specifications?

• Validated assay method for the marker and acceptance limits
• Color photograph of the raw herb
• Marketing claims about traditional use
• Operator names for each batch

Correct Answer: Validated assay method for the marker and acceptance limits

Q10. Which drying method is most appropriate to preserve heat‑sensitive phytoconstituents (e.g., volatile oils, enzymes) in an extract?

• Freeze drying (lyophilization)
• Tray drying at high temperature
• Drum drying
• Open sun drying

Correct Answer: Freeze drying (lyophilization)

Q11. Which type of validation documents that the extraction and downstream processes reproducibly produce material meeting pre‑defined specifications across commercial batches?

• Process validation
• Analytical method validation
• Equipment calibration certificate
• Stability study

Correct Answer: Process validation

Q12. What is the typical solvent system used to prepare tinctures in herbal manufacturing?

• Ethanol–water mixtures of defined strength
• Pure hexane
• Acetone–chloroform mixtures
• Concentrated sulfuric acid

Correct Answer: Ethanol–water mixtures of defined strength

Q13. What is the main advantage of counter‑current extraction compared with simple maceration for herbal raw materials?

• Higher extraction efficiency by constantly contacting fresh solvent with depleted solids
• Complete sterilization of extract
• Significantly shorter subsequent drying time
• Changing the chemical structure of active principles

Correct Answer: Higher extraction efficiency by constantly contacting fresh solvent with depleted solids

Q14. Which description best defines a “standardized herbal extract”?

• An extract that contains a defined concentration of one or more marker compounds and meets specified quality criteria
• A crude powdered herb sold without testing
• A solvent‑free raw herb material
• An extract standardized only by color and odor

Correct Answer: An extract that contains a defined concentration of one or more marker compounds and meets specified quality criteria

Q15. Which guideline specifically addresses good manufacturing practices for herbal medicines and is commonly used internationally by regulators?

• WHO Good Manufacturing Practices for herbal medicines
• Food Safety Modernization Act (FSMA)
• European Pharmacopoeia monograph on tablets
• ICH Q9 Quality Risk Management only

Correct Answer: WHO Good Manufacturing Practices for herbal medicines

Q16. How does the “total ash” test contribute to quality control of herbal drugs and extracts?

• It indicates the presence of inorganic matter such as soil, silicates or added inorganic adulterants
• It directly quantifies active marker concentration
• It measures microbial contamination
• It estimates residual solvent content

Correct Answer: It indicates the presence of inorganic matter such as soil, silicates or added inorganic adulterants

Q17. What is the principal benefit of generating an HPLC or chromatographic fingerprint for a herbal extract?

• Provides a holistic chemical profile that supports identity, batch‑to‑batch consistency and detection of adulteration
• Directly measures microbial limits
• Replaces the need for any marker assays
• Is primarily used to adjust color in finished products

Correct Answer: Provides a holistic chemical profile that supports identity, batch‑to‑batch consistency and detection of adulteration

Q18. Which process parameter is most critical to re‑establish when scaling up an extraction from lab scale to pilot or production scale to maintain similar extract composition?

• Solvent‑to‑solid ratio and contact time (mass transfer conditions)
• Color of production area walls
• Manufacturer of the analytical balance
• Operator preference for stirring speed without documentation

Correct Answer: Solvent‑to‑solid ratio and contact time (mass transfer conditions)

Q19. Which combination of methods is most appropriate for confirming botanical authenticity of starting herbal material used for standardized extracts?

• Macroscopic and microscopic examination combined with DNA barcoding where necessary
• Only HPLC chemical profiling
• Only organoleptic assessment by smell
• Only pH measurement of aqueous extract

Correct Answer: Macroscopic and microscopic examination combined with DNA barcoding where necessary

Q20. What is the practical use of reporting the drug‑extract ratio (DER) on a dry basis for a marketed standardized extract?

• To define how much raw drug (dry weight) is represented by a given weight of extract and ensure dose equivalence
• To indicate the microbial burden of the extract
• To determine the required package size only
• To set the color specification of the final product

Correct Answer: To define how much raw drug (dry weight) is represented by a given weight of extract and ensure dose equivalence

Download