Good Manufacturing Practices (GMP) in traditional systems of medicine MCQs With Answer

Good Manufacturing Practices (GMP) in traditional systems of medicine guide the production of safe, effective and high-quality Ayurvedic, Siddha and Unani formulations. This short overview emphasizes GMP principles tailored for herbal and classical medicines: raw material authentication, Good Agricultural and Collection Practices (GACP), standardization using organoleptic, microscopic and chromatographic methods (TLC, HPLC), equipment qualification, cleaning and process validation, microbial and heavy metal limits, proper packaging, labeling and stability testing. B.Pharm students must grasp documentation, batch records, SOPs, quality assurance versus quality control, and regulatory frameworks (including WHO guidelines and national standards) to prevent adulteration and ensure compliance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of Good Manufacturing Practices (GMP) in traditional systems of medicine?

• Maximize production output regardless of quality
• Ensure safety, consistency and quality of finished products
• Reduce employee training requirements
• Eliminate labeling requirements

Correct Answer: Ensure safety, consistency and quality of finished products

Q2. Which guideline specifically addresses agricultural aspects for medicinal plants used in traditional medicines?

• Good Clinical Practice (GCP)
• Good Agricultural and Collection Practices (GACP)
• Good Laboratory Practice (GLP)
• Good Distribution Practice (GDP)

Correct Answer: Good Agricultural and Collection Practices (GACP)

Q3. Which of the following is a critical step in raw material quality control for herbal drugs?

• Visual marketing strategies
• Botanical identification and authentication
• Reducing particle size for all materials
• Adding synthetic preservatives to increase potency

Correct Answer: Botanical identification and authentication

Q4. Which documentation is essential to trace production history of a batch in a herbal manufacturing unit?

• Batch Manufacturing Record (BMR)
• Employee payroll register
• Market survey report
• Raw material invoice only

Correct Answer: Batch Manufacturing Record (BMR)

Q5. Which analytical technique is commonly used for chemical fingerprinting of herbal medicines?

• Thin Layer Chromatography (TLC)
• X-ray crystallography
• Positron emission tomography
• Electroencephalography

Correct Answer: Thin Layer Chromatography (TLC)

Q6. What is the role of cleaning validation in GMP for traditional medicines?

• To increase production speed
• To ensure removal of residues and prevent cross-contamination
• To reduce the need for trained staff
• To alter product formulation

Correct Answer: To ensure removal of residues and prevent cross-contamination

Q7. Which of the following is considered a critical control point for preventing microbial contamination in herbal products?

• Staff dress code aesthetics
• Controlled humidity and temperature during processing
• Color of production flooring
• Advertising claims

Correct Answer: Controlled humidity and temperature during processing

Q8. In the context of GMP, what does validation of an analytical method ensure?

• The method is cheaper than alternatives
• The method provides reliable, reproducible and appropriate results
• The method does not require documentation
• The method can be used only once

Correct Answer: The method provides reliable, reproducible and appropriate results

Q9. Which parameter is typically NOT part of stability testing for traditional medicines?

• Physical appearance
• Chemical potency
• Microbial limits
• Employee satisfaction

Correct Answer: Employee satisfaction

Q10. What is the significance of a Certificate of Analysis (CoA) for incoming herbal raw materials?

• It certifies the supplier’s marketing plan
• It confirms tested quality attributes and compliance with specifications
• It is a shipping manifest only
• It replaces the need for in-house testing

Correct Answer: It confirms tested quality attributes and compliance with specifications

Q11. Which of the following best describes the difference between Quality Assurance (QA) and Quality Control (QC)?

• QA focuses on product testing; QC focuses on systems and processes
• QA is reactive; QC is proactive
• QA ensures systems and processes are adequate; QC inspects and tests products
• QA and QC are identical and interchangeable

Correct Answer: QA ensures systems and processes are adequate; QC inspects and tests products

Q12. Which government or regulatory framework is commonly referenced for GMP of traditional medicines in India?

• Schedule Y
• Schedule T of the Drugs & Cosmetics Rules
• ICH Q7
• FDA 21 CFR Part 11 exclusively

Correct Answer: Schedule T of the Drugs & Cosmetics Rules

Q13. What is the main purpose of Good Distribution Practice (GDP) as it relates to traditional medicines?

• To regulate advertising campaigns
• To ensure product integrity during storage and transport
• To control employee recruitment
• To standardize production line speed

Correct Answer: To ensure product integrity during storage and transport

Q14. Which contamination is of special concern in herbal materials due to field exposure?

• Radioactive isotopes only
• Pesticide residues and heavy metals
• Excessive oxygen
• High vitamin content

Correct Answer: Pesticide residues and heavy metals

Q15. What is an appropriate action when a deviation from SOP occurs during production?

• Ignore it if product looks normal
• Record the deviation, investigate root cause and implement CAPA
• Destroy all documentation
• Change the batch number to hide the deviation

Correct Answer: Record the deviation, investigate root cause and implement CAPA

Q16. Which practice helps ensure identity of powdered herbal raw materials?

• Microscopic examination and organoleptic tests
• Increasing powder fineness only
• Relying solely on supplier labels
• Packaging in opaque containers only

Correct Answer: Microscopic examination and organoleptic tests

Q17. Why are SOPs (Standard Operating Procedures) crucial in GMP?

• They increase paperwork without benefit
• They provide consistent instructions to ensure reproducible processes
• They replace training requirements
• They allow flexible undocumented practices

Correct Answer: They provide consistent instructions to ensure reproducible processes

Q18. Which test is commonly used to detect certain microbial pathogens in finished herbal products?

• Salmonella and Escherichia coli detection tests
• Cholesterol assay
• Electrolyte balance test
• Blood glucose monitoring

Correct Answer: Salmonella and Escherichia coli detection tests

Q19. What does IQ, OQ and PQ refer to in equipment qualification?

• Inspection, Operation, Production
• Installation Qualification, Operational Qualification, Performance Qualification
• Internal Quality, Outside Quality, Product Quality
• Input Quantity, Output Quantity, Process Quality

Correct Answer: Installation Qualification, Operational Qualification, Performance Qualification

Q20. Which documentation must accompany a finished herbal product for regulatory compliance and traceability?

• Batch packaging record and Certificate of Analysis
• Only marketing brochures
• Employee attendance sheets
• Supplier promotional material

Correct Answer: Batch packaging record and Certificate of Analysis

Q21. Fingerprint chromatography in herbal standardization is used to:

• Measure particle size distribution only
• Provide a comprehensive chemical profile for identity and consistency
• Replace the need for any biological testing
• Determine product color preferences

Correct Answer: Provide a comprehensive chemical profile for identity and consistency

Q22. Which packaging attribute is important to preserve stability of traditional medicines?

• Material compatibility and moisture protection
• Maximum transparency to light
• Loose seals for ventilation
• Packaging with no label

Correct Answer: Material compatibility and moisture protection

Q23. What is the function of a change control system in GMP-regulated manufacturing?

• To allow uncontrolled product changes
• To assess, approve and document any changes affecting quality
• To stop all product improvements indefinitely
• To delegate quality decisions to marketing

Correct Answer: To assess, approve and document any changes affecting quality

Q24. Which parameter is key when establishing shelf-life for herbal formulations?

• Random selection of expiry dates
• Stability data under defined storage conditions
• Supplier recommendations only
• Packaging color trends

Correct Answer: Stability data under defined storage conditions

Q25. Which international document provides guidance on GMP for herbal medicines?

• WHO guidelines on Good Manufacturing Practices for herbal medicines
• HIPAA privacy rule
• ISO 9001 exclusively for software
• ICH E6 only

Correct Answer: WHO guidelines on Good Manufacturing Practices for herbal medicines

Q26. Why is supplier qualification important in GMP for traditional medicines?

• To ensure raw material price is lowest
• To verify consistent quality, traceability and compliance of supplied materials
• To reduce documentation requirements
• To bypass incoming inspection

Correct Answer: To verify consistent quality, traceability and compliance of supplied materials

Q27. Which is a common method to detect heavy metal contamination in herbal samples?

• Atomic Absorption Spectroscopy (AAS)
• Simple pH paper test
• Microscopic pollen analysis
• Organoleptic tasting

Correct Answer: Atomic Absorption Spectroscopy (AAS)

Q28. What is the role of an internal audit in a GMP quality system?

• To punish staff for minor mistakes
• To objectively assess compliance and identify improvement areas
• To replace external inspections permanently
• To delay corrective actions

Correct Answer: To objectively assess compliance and identify improvement areas

Q29. Which practice helps prevent adulteration and substitution of herbal raw materials?

• Comprehensive botanical authentication and supplier audits
• Relying on cheaper substitutes
• Accepting materials without testing
• Using only visual inspection of intact plants

Correct Answer: Comprehensive botanical authentication and supplier audits

Q30. During a regulatory inspection, which evidence best demonstrates effective GMP implementation?

• Well-maintained SOPs, batch records, training logs and test reports
• High sales figures
• Colorful office decor
• Unsigned and undated forms

Correct Answer: Well-maintained SOPs, batch records, training logs and test reports

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