Good Laboratory Practices (GLP) in traditional systems of medicine are essential for ensuring reliable, reproducible and auditable laboratory data in herbal and traditional drug research. This introduction covers key concepts such as documentation, SOPs, quality assurance, method validation, equipment qualification, sample handling, reference standards, stability studies, contamination control (microbial, heavy metals, pesticides), data integrity and ethical standards. B. Pharm students will learn how GLP principles support standardization, safety assessment and regulatory compliance during preclinical and analytical studies of herbal medicines. Emphasis on traceability, calibration, validation parameters and CAPA strengthens laboratory credibility and product quality. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of Good Laboratory Practices (GLP) in traditional systems of medicine?
- Ensure reliability, reproducibility and integrity of non-clinical laboratory data
- Guarantee immediate market approval of herbal products
- Reduce laboratory running costs
- Replace clinical trials for safety assessment
Correct Answer: Ensure reliability, reproducibility and integrity of non-clinical laboratory data
Q2. GLP primarily applies to which type of studies?
- Non-clinical laboratory studies such as safety, toxicology and analytical testing
- Phase III clinical trials
- Marketing and sales studies
- Post-marketing pharmacovigilance only
Correct Answer: Non-clinical laboratory studies such as safety, toxicology and analytical testing
Q3. Which unit in the laboratory is chiefly responsible for monitoring GLP compliance?
- Quality Assurance (QA) unit
- Human Resources department
- Sales and Distribution unit
- Regulatory Affairs only
Correct Answer: Quality Assurance (QA) unit
Q4. What does the acronym SOP mean in a GLP laboratory?
- Standard Operating Procedure
- Sample Observation Plan
- Systematic Order Protocol
- Standard Optional Procedure
Correct Answer: Standard Operating Procedure
Q5. The purpose of chain-of-custody documentation is to:
- Track sample collection, transfer and custody to ensure traceability
- Reduce the number of tests required
- Improve the appearance of product labels
- Ensure marketing approval
Correct Answer: Track sample collection, transfer and custody to ensure traceability
Q6. Which validation parameter describes closeness of the measured value to the true value?
- Accuracy
- Precision
- Linearity
- Robustness
Correct Answer: Accuracy
Q7. Which term best describes repeatability of results under unchanged conditions?
- Precision
- Specificity
- Sensitivity
- Stability
Correct Answer: Precision
Q8. LOD (limit of detection) and LOQ (limit of quantification) primarily relate to which characteristic?
- Analytical sensitivity
- Method ruggedness
- System suitability
- Storage stability
Correct Answer: Analytical sensitivity
Q9. IQ/OQ/PQ activities are performed to qualify what?
- Laboratory equipment and instruments
- Marketing strategies
- Clinical trial protocols
- Human resources policies
Correct Answer: Laboratory equipment and instruments
Q10. Retention (reserve) samples are kept in GLP labs to:
- Allow reanalysis, stability checks and dispute resolution
- Increase inventory for production
- Provide materials for marketing samples
- Dispose of excess material quickly
Correct Answer: Allow reanalysis, stability checks and dispute resolution
Q11. Good documentation practice requires corrections to be made by:
- Single-line strike-through, initial, date and reason (no erasures)
- Using correction fluid to hide the error
- Erasing and rewriting without note
- Leaving the error and not noting it
Correct Answer: Single-line strike-through, initial, date and reason (no erasures)
Q12. A reference standard in herbal analysis is used to:
- Authenticate identity and quantify marker compounds
- Replace raw material testing entirely
- Promote the product in the market
- Determine patient dosage in clinical trials
Correct Answer: Authenticate identity and quantify marker compounds
Q13. Why is a herbarium voucher specimen important in GLP for herbal research?
- Provides botanical authentication and reference for raw material identity
- Acts as the final product label
- Is used as an alternative to chemical testing
- Reduces the need for stability studies
Correct Answer: Provides botanical authentication and reference for raw material identity
Q14. Microbial limit testing in traditional medicine raw materials is performed to:
- Ensure acceptable levels of microbial contamination and product safety
- Enhance flavor and aroma
- Reduce assay variability only
- Determine heavy metal content
Correct Answer: Ensure acceptable levels of microbial contamination and product safety
Q15. Testing for heavy metals in herbal materials is necessary because:
- Heavy metals are toxic and regulated with specified limits
- They improve therapeutic efficacy
- They are required for labeling color
- They indicate shelf life
Correct Answer: Heavy metals are toxic and regulated with specified limits
Q16. The main goal of accelerated stability studies is to:
- Predict shelf life and select suitable storage conditions
- Increase marketing claims
- Replace real-time stability completely
- Test packaging aesthetics
Correct Answer: Predict shelf life and select suitable storage conditions
Q17. How should calibration frequency for critical instruments be determined?
- Based on manufacturer recommendations, instrument use and historical performance
- Only once at installation
- Whenever the instrument fails completely
- Never, if the instrument looks fine
Correct Answer: Based on manufacturer recommendations, instrument use and historical performance
Q18. ALCOA is a data integrity principle. What does it stand for?
- Attributable, Legible, Contemporaneous, Original, Accurate
- Analytical, Logically Organized, Consistent, Original, Archived
- Accessible, Legible, Current, Observable, Accurate
- Available, Linked, Collected, Organized, Archived
Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate
Q19. A deviation report in GLP should include:
- Detailed description, root cause analysis and corrective and preventive actions (CAPA)
- Only the name of the operator involved
- Just a signature without details
- Only the date when it occurred
Correct Answer: Detailed description, root cause analysis and corrective and preventive actions (CAPA)
Q20. What is a key difference between GLP and GMP?
- GLP focuses on non-clinical laboratory study quality; GMP focuses on manufacturing quality and control
- GLP governs marketing activities while GMP governs research only
- They are identical and interchangeable
- GMP applies only to raw herbal materials
Correct Answer: GLP focuses on non-clinical laboratory study quality; GMP focuses on manufacturing quality and control
Q21. In method validation, linearity assesses:
- That response is directly proportional to analyte concentration over a specified range
- How precise a method is under the same conditions
- How well a method resists small deliberate changes
- How low the method can detect analytes
Correct Answer: That response is directly proportional to analyte concentration over a specified range
Q22. Cleaning validation in shared equipment facilities ensures:
- No cross-contamination between different herbal batches or products
- Faster production times
- Higher product odor
- Less documentation is required
Correct Answer: No cross-contamination between different herbal batches or products
Q23. A Certificate of Analysis (CoA) typically contains:
- Test results, specifications, batch identification and analyst details
- Marketing slogans and sales data
- Only the product price
- Employee payroll information
Correct Answer: Test results, specifications, batch identification and analyst details
Q24. Who is normally authorized to approve and sign Standard Operating Procedures (SOPs) in a GLP lab?
- The Quality Assurance (QA) manager or designee
- The janitorial staff
- Any random laboratory trainee
- The marketing manager
Correct Answer: The Quality Assurance (QA) manager or designee
Q25. The term “bioburden” in herbal raw materials refers to:
- The level of viable microorganisms present
- The amount of heavy metals
- The concentration of active marker compounds
- The water content only
Correct Answer: The level of viable microorganisms present
Q26. Good sampling practice in GLP requires:
- Use of a representative sampling plan and documented procedure
- Random taking of any quantity without documentation
- Sampling only after product release
- Sampling by marketing staff
Correct Answer: Use of a representative sampling plan and documented procedure
Q27. Why are marker compounds used for standardization of herbal extracts?
- To ensure consistent potency, identity and batch-to-batch comparability
- To increase product viscosity
- To avoid any analytical testing
- To replace botanical authentication
Correct Answer: To ensure consistent potency, identity and batch-to-batch comparability
Q28. A stability-indicating method is defined as:
- An analytical method that accurately measures the active and separates degradation products
- A method that only measures packaging quality
- A technique used only for microbial limits
- A test for visual appearance only
Correct Answer: An analytical method that accurately measures the active and separates degradation products
Q29. In bioassays and analytical tests, positive and negative controls are used to:
- Verify assay performance, specificity and sensitivity
- Eliminate the need for standards
- Increase sample throughput without validation
- Reduce instrument calibration needs
Correct Answer: Verify assay performance, specificity and sensitivity
Q30. For GLP, training of laboratory personnel should be:
- Initial and documented periodic refresher training with competency assessment
- Optional and undocumented
- Only for senior management
- Limited to online videos with no records
Correct Answer: Initial and documented periodic refresher training with competency assessment
very good questions