Quality assurance in ISM: GAP, GMP and GLP implementation MCQs With Answer

Introduction: Quality assurance in ISM: GAP, GMP and GLP implementation MCQs With Answer is a focused question bank designed for M.Pharm students specializing in Indian Systems of Medicine. This resource emphasizes practical and regulatory aspects of Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to herbal drug production, processing and analytical evaluation. Questions cover sourcing and traceability of raw materials, documentation, validation, contamination control, analytical method integrity, stability testing and regulatory compliance specific to ISM. The set aims to strengthen conceptual understanding, prepare students for exams and audits, and support implementation of robust quality systems in AYUSH contexts.

Q1. Which element of GAP is most critical to ensure phytochemical consistency in ISM raw materials?

• Post-harvest drying technique
• Depth of soil sampling
• Standardized cultivation and harvest timing
• Packaging material selection

Correct Answer: Standardized cultivation and harvest timing

Q2. Under GMP for ISM, which document defines the step-by-step manufacturing process, critical parameters and in-process controls?

• Master Formula Record
• Certificate of Analysis
• Environmental Monitoring Log
• Stability Protocol

Correct Answer: Master Formula Record

Q3. Which practice is primarily related to GLP to maintain integrity of analytical data in herbal medicine testing?

• Frequent marketing surveys
• Use of uncontrolled reference standards
• Complete raw data archiving with traceable timestamps
• Outsourcing all stability studies without oversight

Correct Answer: Complete raw data archiving with traceable timestamps

Q4. What is the main objective of cleaning validation in an ISM manufacturing facility?

• To reduce electricity consumption
• To ensure residues from previous batches do not contaminate subsequent products
• To document employee attendance
• To validate packaging aesthetics

Correct Answer: To ensure residues from previous batches do not contaminate subsequent products

Q5. Which guideline or compendium provides monographs and specifications for many Indian herbal drugs used in ISM?

• European Pharmacopoeia
• Ayurvedic Pharmacopoeia of India (API)
• British Herbal Compendium
• United States Pharmacopeia (USP) only

Correct Answer: Ayurvedic Pharmacopoeia of India (API)

Q6. During a GMP audit, which observation would most strongly suggest inadequate personnel training in an ISM facility?

• Well-maintained calibration records
• Incorrect execution of SOPs with no corrective actions
• Comprehensive batch release documentation
• Routine environmental monitoring within limits

Correct Answer: Incorrect execution of SOPs with no corrective actions

Q7. Which analytical test is essential under GLP for assessing microbial safety of liquid herbal formulations?

• Dissolution testing
• Microbial limit test and absence of specified pathogens
• Particle size distribution
• Density measurement

Correct Answer: Microbial limit test and absence of specified pathogens

Q8. Traceability in GAP for ISM raw materials primarily requires documentation of what?

• Final product pricing
• Source, cultivar, harvest date and post-harvest handling
• Office stationery suppliers
• Retail distribution map only

Correct Answer: Source, cultivar, harvest date and post-harvest handling

Q9. Which component of a quality management system handles identification and prevention of recurring deviations in an ISM manufacturer?

• Promotional department
• Corrective and Preventive Action (CAPA) system
• Sales forecasting team
• Packaging design committee

Correct Answer: Corrective and Preventive Action (CAPA) system

Q10. In GLP compliance, what is the primary role of the Study Director or Responsible Scientist?

• To approve facility hiring decisions
• To oversee conduct of the study and ensure scientific integrity
• To manage accounting and payroll
• To conduct routine equipment maintenance

Correct Answer: To oversee conduct of the study and ensure scientific integrity

Q11. Which parameter is a critical quality attribute for powdered herbal formulations that should be controlled under GMP?

• Tablet scoring depth
• Bulk density and particle size distribution
• Printer model used for labels
• Number of retail outlets

Correct Answer: Bulk density and particle size distribution

Q12. What is the purpose of a Certificate of Analysis (CoA) in ISM raw material supply chain?

• To list distributors only
• To provide analytical results verifying material meets specified quality criteria
• To indicate marketing claims
• To certify employee salaries

Correct Answer: To provide analytical results verifying material meets specified quality criteria

Q13. Which activity is a core requirement of GAP to minimise contamination by pesticides and heavy metals?

• Random selection of seeds
• Soil testing, controlled use of agrochemicals and buffer zones
• Using any available irrigation source without testing
• Harvesting irrespective of maturity

Correct Answer: Soil testing, controlled use of agrochemicals and buffer zones

Q14. Which of the following is an essential element of batch release under GMP for an ISM product?

• Approval by the QA unit after review of all manufacturing and QC records
• Approval by marketing team only
• Immediate release without review to meet sales targets
• Release based solely on visual inspection

Correct Answer: Approval by the QA unit after review of all manufacturing and QC records

Q15. Under GLP, why is system suitability testing performed before running analytical samples?

• To calibrate office printers
• To ensure the analytical system is functioning properly and results will be reliable
• To estimate product shelf life visually
• To validate personnel attendance

Correct Answer: To ensure the analytical system is functioning properly and results will be reliable

Q16. Which documentation practice helps prevent mix-ups between similar herbal raw materials in GMP-compliant ISM manufacturing?

• Labeling with unique batch numbers and botanical identity verification
• Storing all materials without segregation
• Relying on memory of staff
• Using identical packaging for different herbs

Correct Answer: Labeling with unique batch numbers and botanical identity verification

Q17. Which validation demonstrates that a cleaning procedure consistently removes contaminants to acceptable levels?

• Analytical method validation only
• Cleaning validation using worst-case residues and validated analytical detection limits
• Packaging validation only
• Employee training validation

Correct Answer: Cleaning validation using worst-case residues and validated analytical detection limits

Q18. For herbal drug stability studies under GMP, which condition is typically required to claim a shelf life?

• Stability testing under defined temperature and humidity conditions with validated assays
• Storage at random uncontrolled conditions
• Short-term visual inspections only
• Testing only the starting raw material

Correct Answer: Stability testing under defined temperature and humidity conditions with validated assays

Q19. Which body or accreditation is commonly sought by analytical laboratories in India to demonstrate technical competence relevant to GLP/GMP testing?

• NABL (National Accreditation Board for Testing and Calibration Laboratories)
• ISO entertainment certification
• Local business chamber only
• Retailer association membership

Correct Answer: NABL (National Accreditation Board for Testing and Calibration Laboratories)

Q20. Which of the following best describes the role of pharmacovigilance in ISM quality systems?

• Monitoring sales performance
• Collecting, evaluating and acting on adverse event reports to ensure safety of traditional products
• Designing commercial packaging
• Tracking shipment logistics only

Correct Answer: Collecting, evaluating and acting on adverse event reports to ensure safety of traditional products

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