Introduction: Current Good Manufacturing Practices (cGMP) for herbal medicines, based on WHO guidelines, ensure safety, quality and efficacy across the product life cycle. B. Pharm students must understand key concepts: raw material sourcing and authentication, Good Agricultural and Collection Practices (GACP), standard operating procedures (SOPs), quality assurance, quality control testing (identity, purity, potency), documentation, validation, contamination control, and traceability. Emphasis on herbal-specific issues — botanical identification, pesticide/heavy metal limits, microbial contamination, extraction solvents and stability — is essential for regulatory compliance. Mastery of these topics prepares students to design, audit and improve herbal manufacturing systems. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which of the following best describes the primary purpose of cGMP for herbal medicines according to WHO guidelines?
- To maximize production speed and reduce costs
- To ensure consistent quality, safety, and efficacy of herbal products
- To standardize marketing and advertising claims
- To mandate traditional uses for all botanicals
Correct Answer: To ensure consistent quality, safety, and efficacy of herbal products
Q2. Which document is essential in cGMP to describe routine manufacturing steps and ensure reproducibility?
- Marketing dossier
- Standard Operating Procedure (SOP)
- Patient information leaflet
- Research grant proposal
Correct Answer: Standard Operating Procedure (SOP)
Q3. What is the WHO-recommended practice for sourcing botanical raw materials to minimize adulteration?
- Randomly purchase from markets
- Use Good Agricultural and Collection Practices (GACP) and documented supplier qualification
- Rely only on visual inspection at point of receipt
- Buy from the lowest-cost supplier
Correct Answer: Use Good Agricultural and Collection Practices (GACP) and documented supplier qualification
Q4. Which analytical method is commonly recommended for herbal identity testing in WHO guidelines?
- Thin-layer chromatography (TLC)/HPTLC and macroscopic/microscopic examination
- Only organoleptic testing
- Colorimetry without reference standards
- Random chemical screening without validation
Correct Answer: Thin-layer chromatography (TLC)/HPTLC and macroscopic/microscopic examination
Q5. In herbal GMP, what does “traceability” primarily refer to?
- Tracking finished product sales
- Ability to follow raw material and product history from source to finished product
- Keeping employee attendance records
- Recording advertising channels
Correct Answer: Ability to follow raw material and product history from source to finished product
Q6. Which of the following is a critical control for preventing microbial contamination in herbal products?
- Storage at ambient temperature without monitoring
- Validated cleaning and sanitization, environmental monitoring, and microbial limits testing
- Using only powdered raw materials
- Eliminating QC testing to speed production
Correct Answer: Validated cleaning and sanitization, environmental monitoring, and microbial limits testing
Q7. What is the role of validation in cGMP for herbal manufacturing?
- To provide marketing claims
- To demonstrate that processes, methods and equipment consistently produce quality products
- To replace routine testing
- To certify suppliers indefinitely
Correct Answer: To demonstrate that processes, methods and equipment consistently produce quality products
Q8. Which parameter is especially important to monitor for solvent-based herbal extracts?
- Residual solvent levels and compliance with limits
- Color only
- Presence of inorganic salts
- Package design
Correct Answer: Residual solvent levels and compliance with limits
Q9. According to WHO, what documentation should accompany incoming herbal raw materials?
- Invoice only
- Certificate of analysis, botanical identification, collection data and supplier certificate
- Marketing brochure
- Manufacturer confidential notes
Correct Answer: Certificate of analysis, botanical identification, collection data and supplier certificate
Q10. Which quality attribute is most directly assessed by assay or potency testing in herbal products?
- Label design
- Active constituent content and potency
- Container weight
- Supplier location
Correct Answer: Active constituent content and potency
Q11. What is a common WHO recommendation for preventing heavy metal contamination in herbal medicines?
- Ignore heavy metal testing for natural products
- Set and test against specified heavy metal limits; control soil and sourcing
- Rely solely on consumer feedback
- Wash finished products only
Correct Answer: Set and test against specified heavy metal limits; control soil and sourcing
Q12. In quality management, what does CAPA stand for and why is it important in cGMP?
- Corrective Action and Preventive Action; to address deviations and prevent recurrence
- Control And Product Assurance; to automate manufacturing
- Calibration And Procedure Audit; to reduce costs
- Certification and Product Allocation; to manage inventory
Correct Answer: Corrective Action and Preventive Action; to address deviations and prevent recurrence
Q13. Which practice helps ensure botanical authenticity when morphological identification is inconclusive?
- Use of DNA barcoding or chemical fingerprinting (HPTLC/HPLC)
- Assume identity based on supplier name
- Rely on taste alone
- Use only pack size as evidence
Correct Answer: Use of DNA barcoding or chemical fingerprinting (HPTLC/HPLC)
Q14. What is the significance of stability studies for herbal medicines under cGMP?
- To determine labeling claims for shelf life and storage conditions
- Only to check container strength
- To monitor employee performance
- To set marketing price
Correct Answer: To determine labeling claims for shelf life and storage conditions
Q15. Which element is a part of Good Documentation Practice (GDP) in cGMP?
- Backdating corrected records to match production
- Legible, dated entries with initials, traceable changes and retention
- Erasing errors without record
- Allowing unauthorized personnel to edit records
Correct Answer: Legible, dated entries with initials, traceable changes and retention
Q16. For herbal product packaging, WHO cGMP emphasizes that packaging should primarily:
- Be colourful to attract consumers
- Protect product quality by preventing contamination, moisture and light damage
- Be as large as possible
- Include promotional inserts only
Correct Answer: Protect product quality by preventing contamination, moisture and light damage
Q17. Which of the following is a key element of personnel requirements in WHO cGMP for herbal manufacturing?
- Hiring only botanists
- Training, hygiene, defined responsibilities and medical surveillance as appropriate
- No training is required
- Personnel should self-train on the job
Correct Answer: Training, hygiene, defined responsibilities and medical surveillance as appropriate
Q18. What is the purpose of an incoming raw material quarantine area in herbal GMP?
- To mix materials before testing
- To hold materials until identity and quality are confirmed by QC
- To display samples for sales
- To store waste materials
Correct Answer: To hold materials until identity and quality are confirmed by QC
Q19. Which practice helps minimize pesticide residues in finished herbal products?
- Ignoring pesticide testing if plants look clean
- Implementing GACP, supplier control and routine pesticide residue analysis
- Using more fertilizer during cultivation
- Drying herbs at very high temperatures regardless of stability
Correct Answer: Implementing GACP, supplier control and routine pesticide residue analysis
Q20. What is an appropriate response to a non-conforming batch discovered during QC testing?
- Release the batch immediately to avoid losses
- Quarantine the batch, investigate root cause, initiate CAPA and decide disposition
- Ignore the result
- Destroy all records related to the batch
Correct Answer: Quarantine the batch, investigate root cause, initiate CAPA and decide disposition
Q21. Which of these best reflects WHO guidance on standardization of herbal extracts?
- Standardization is unnecessary for traditional products
- Define and control marker compounds, extraction parameters and potency limits
- Only control final capsule weight
- Standardize only packaging color
Correct Answer: Define and control marker compounds, extraction parameters and potency limits
Q22. Why is environmental monitoring important in herbal manufacturing areas?
- To reduce electricity bills
- To detect and control particulate, microbial and airborne contamination risks
- To ensure the building is aesthetically pleasing
- To replace final product testing entirely
Correct Answer: To detect and control particulate, microbial and airborne contamination risks
Q23. What is the role of a quality assurance (QA) unit in cGMP compliance for herbal medicines?
- To only approve sales strategies
- To oversee GMP adherence, review documentation, and approve/reject batches
- To manage cafeteria services
- To hire external marketing agencies
Correct Answer: To oversee GMP adherence, review documentation, and approve/reject batches
Q24. Which testing is essential to detect possible mycotoxin contamination in herbal raw materials?
- Mycotoxin analysis by validated methods such as HPLC or LC-MS/MS
- Only pH testing
- Organoleptic tasting
- Checking package weight
Correct Answer: Mycotoxin analysis by validated methods such as HPLC or LC-MS/MS
Q25. In cGMP, what is the importance of change control for processes and equipment?
- To allow undocumented changes at will
- To evaluate, document and approve changes to prevent negative impacts on product quality
- To speed up product launch by skipping approvals
- To limit employee input on improvements
Correct Answer: To evaluate, document and approve changes to prevent negative impacts on product quality
Q26. Which record is critical for demonstrating compliance with WHO guidelines during an inspection?
- Employee social media posts
- Complete batch manufacturing records and QC test reports
- Personal notes of managers
- Supplier marketing brochures
Correct Answer: Complete batch manufacturing records and QC test reports
Q27. For herbal medicines, what does “adulteration” typically mean in a cGMP context?
- Adding non-declared or cheaper plant material, synthetic drugs or contaminants
- Proper drying of herbs
- Using traditional recipes only
- Labeling with multiple languages
Correct Answer: Adding non-declared or cheaper plant material, synthetic drugs or contaminants
Q28. Which practice helps assure consistency between different batches of a herbal extract?
- Variable extraction time for each batch
- Process validation, consistent raw material specification and in-process controls
- Changing suppliers each batch
- Not measuring active content
Correct Answer: Process validation, consistent raw material specification and in-process controls
Q29. What is the recommended approach to labeling herbal medicinal products under WHO cGMP?
- Include accurate ingredient list, batch number, manufacturing and expiry dates, storage conditions and warnings
- Only list the brand name
- Include claims without evidence
- Use opaque labels without batch information
Correct Answer: Include accurate ingredient list, batch number, manufacturing and expiry dates, storage conditions and warnings
Q30. Which of the following best describes the role of stability-indicating methods in herbal product analysis?
- Methods that detect degradation products and quantify active markers through shelf life studies
- Only measure initial pH
- Track employee shift patterns
- Assess packaging aesthetics
Correct Answer: Methods that detect degradation products and quantify active markers through shelf life studies
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