Quality assurance: TQM, GMP, GLP, ISO-9000 for herbal products MCQs With Answer

Introduction

This quiz collection on Quality Assurance — covering TQM, GMP, GLP and ISO-9000 as applied to herbal products — is designed for M. Pharm students specializing in Industrial Pharmacognostical Technology. The questions focus on practical regulatory requirements, system-level quality management, laboratory and manufacturing controls, and herbal-specific challenges such as botanical identification, standardization and contamination risks. Each MCQ tests conceptual understanding and application: process controls, documentation, validation, risk-based thinking, and audit-ready practices. Use these items to evaluate and deepen your grasp of how international quality frameworks are implemented for complex, variable herbal materials and finished products in pharmaceutical practice.

Q1. Which of the following is a core principle of Total Quality Management (TQM) in pharmaceutical manufacturing?

• Cost-cutting as the primary objective
• Customer focus and continual improvement
• Relying solely on end-product inspection
• Minimizing documentation to accelerate production

Correct Answer: Customer focus and continual improvement

Q2. In ISO 9001:2015 which clause is most closely associated with introducing risk-based thinking into a quality management system?

• Leadership (Clause 5)
• Planning (Clause 6)
• Support (Clause 7)
• Performance evaluation (Clause 9)

Correct Answer: Planning (Clause 6)

Q3. Which statement best distinguishes GMP from GLP in the context of herbal products?

• GMP applies only to clinical trials, GLP applies only to manufacturing
• GMP ensures quality during manufacture of products; GLP ensures reliability and integrity of non‑clinical laboratory studies
• GMP is optional for herbal products while GLP is mandatory
• GMP focuses on environmental testing while GLP focuses on marketing claims

Correct Answer: GMP ensures quality during manufacture of products; GLP ensures reliability and integrity of non‑clinical laboratory studies

Q4. For robust botanical identification of an incoming herbal raw material, the most reliable approach is:

• Macroscopic examination only
• Chemical assay (single marker) only
• DNA barcoding only
• Combination of macroscopic, microscopic, DNA barcoding and chemical fingerprinting

Correct Answer: Combination of macroscopic, microscopic, DNA barcoding and chemical fingerprinting

Q5. A critical GMP requirement when producing concentrated herbal extracts involving organic solvents is:

• Assuming solvent is evaporated completely without testing
• Validating solvent removal processes and testing residual solvent against established limits
• Using any solvent as long as extraction yield is high
• Documenting solvent type but not testing residues

Correct Answer: Validating solvent removal processes and testing residual solvent against established limits

Q6. Under GLP the Study Director is best described as:

• The single point of control and responsible official for the technical conduct of the study
• The external sponsor who funds the study
• The laboratory technician performing all assays
• The auditor who inspects the study at the end

Correct Answer: The single point of control and responsible official for the technical conduct of the study

Q7. Which ISO 9001 principle requires visible commitment and accountability from top management?

• Customer focus
• Leadership
• Evidence-based decision making
• Process approach

Correct Answer: Leadership

Q8. When defining specifications for a finished herbal product, which set of quality attributes is essential to include?

• Only appearance and color
• Assay of marker compounds, microbial limits and heavy metal specification
• Packaging design details only
• Only moisture content

Correct Answer: Assay of marker compounds, microbial limits and heavy metal specification

Q9. Which TQM quality tool is most appropriate for systematic root-cause analysis of a recurring contamination event in a herb processing line?

• Pareto chart
• Fishbone (Ishikawa) diagram
• Control chart
• Scatter plot

Correct Answer: Fishbone (Ishikawa) diagram

Q10. Under GLP principles, raw data, protocols, final reports and retained samples should be:

• Disposed of immediately after study completion
• Archived and retained as specified by the study plan and applicable regulations
• Kept only if the study is successful
• Shared publicly without restriction

Correct Answer: Archived and retained as specified by the study plan and applicable regulations

Q11. Which ISO 9001 principle explicitly supports the organization’s need for continual improvement?

• Engagement of people
• Improvement
• Factual approach to decision making
• Relationship management

Correct Answer: Improvement

Q12. Which GMP documentation principle is correctly stated for manufacturing herbal medicines?

• If it is not documented, it is assumed to have been done correctly
• If it is not documented, it did not happen
• Verbal approval is sufficient in place of documented change control
• Only batch quantity needs to be recorded, not procedures

Correct Answer: If it is not documented, it did not happen

Q13. Which of the following represents major quality risks unique to herbal product manufacture?

• Variability in active constituents due to botanical source
• Adulteration and substitution of raw herbs
• Pesticide, heavy metal and microbial contamination
• All of the above

Correct Answer: All of the above

Q14. Which validation parameter ensures an analytical method can unambiguously measure the analyte in presence of other components?

• Accuracy
• Precision
• Specificity/selectivity
• Linearity

Correct Answer: Specificity/selectivity

Q15. Which statement correctly describes the roles of Quality Assurance (QA) and Quality Control (QC)?

• QA performs only laboratory tests while QC manages the quality system
• QA ensures systems and processes are in place; QC performs sampling and analytical testing to verify product quality
• QA and QC are interchangeable titles with identical responsibilities
• QC approves SOPs while QA writes them

Correct Answer: QA ensures systems and processes are in place; QC performs sampling and analytical testing to verify product quality

Q16. A robust GMP change control process for a herbal extract production process should include which activities?

• Technical evaluation of the change
• Approval, documentation and training of affected personnel
• Assessment of impact on specifications, validation and regulatory filings
• All of the above

Correct Answer: All of the above

Q17. Which of the following is a recognized benefit of implementing ISO 9001 certification for a herbal pharmaceutical manufacturer?

• Improved internal process control and consistent product quality
• Enhanced customer confidence and market access
• Framework for continual improvement and documented procedures
• All of the above

Correct Answer: All of the above

Q18. Establishing acceptable pesticide residue limits for finished herbal products should be based on:

• Arbitrary values chosen by the manufacturing team
• Regulatory maximum residue limits (MRLs) and toxicological risk assessment
• Only the most sensitive analytical method detection limit
• Historical levels detected in raw material without risk assessment

Correct Answer: Regulatory maximum residue limits (MRLs) and toxicological risk assessment

Q19. In TQM the PDCA cycle stands for which sequence?

• Prepare-Do-Check-Adjust
• Plan-Do-Check-Act
• Plan-Develop-Control-Act
• Predict-Do-Confirm-Act

Correct Answer: Plan-Do-Check-Act

Q20. Good Distribution Practices (GDP) for herbal products emphasize which of the following to maintain quality through the supply chain?

• Traceability, documentation and appropriate storage to prevent mix-ups and degradation
• Only marketing activities and promotions
• Minimizing paperwork to speed shipments
• Outsourcing all distribution tasks without oversight

Correct Answer: Traceability, documentation and appropriate storage to prevent mix-ups and degradation

Download