GMP for herbal cosmetic manufacturing MCQs With Answer

Introduction:

This quiz compilation on “GMP for herbal cosmetic manufacturing” is tailored for M.Pharm (Herbal Cosmetics MPG 204T) students preparing for exams and practical quality assurance roles. It focuses on Good Manufacturing Practices specific to herbal formulations—covering facility design, personnel hygiene, raw-materials control, validation, documentation, microbial control, preservative testing, labeling and regulatory standards such as ISO 22716. Questions probe deeper concepts like botanical identification, cleaning validation, supplier qualification, contamination control, stability considerations and cosmeceutical safety assessments. Each item includes a correct answer to help reinforce learning and prepare students for both theory examinations and real-world quality management tasks in herbal cosmetic production.

Q1. What is the primary objective of GMP in herbal cosmetic manufacturing?

• To maximize production output regardless of quality
• To ensure consistent product quality, safety and regulatory compliance
• To minimize raw material costs
• To promote the brand through marketing

Correct Answer: To ensure consistent product quality, safety and regulatory compliance

Q2. Which international guideline is most widely recognized for cosmetic GMP?

• WHO Technical Report Series
• ISO 22716
• ICH Q7
• USP General Chapter

Correct Answer: ISO 22716

Q3. For herbal raw materials, which of the following best ensures botanical authenticity?

• Only supplier’s COA without in-house verification
• Macroscopic and microscopic examination plus chromatographic fingerprinting or DNA barcoding
• Visual inspection of packaging only
• Relying solely on common/trade names

Correct Answer: Macroscopic and microscopic examination plus chromatographic fingerprinting or DNA barcoding

Q4. Which microbial test is essential for finished herbal cosmetic products to evaluate preservative effectiveness?

• Antibiotic susceptibility test
• Preservative Efficacy Test / Challenge Test
• Water hardness test
• Heavy metals assay

Correct Answer: Preservative Efficacy Test / Challenge Test

Q5. What is the purpose of cleaning validation in GMP for herbal cosmetics?

• To document employee working hours
• To verify that cleaning procedures consistently remove product residues, contaminants and cleaning agents to acceptable limits
• To increase batch throughput
• To validate marketing claims

Correct Answer: To verify that cleaning procedures consistently remove product residues, contaminants and cleaning agents to acceptable limits

Q6. Which water quality is most appropriate as an ingredient in rinse-off herbal cosmetic formulations?

• Untreated well water
• Purified water meeting pharmacopeial specifications
• Tap water without treatment
• Distilled water only for equipment cleaning

Correct Answer: Purified water meeting pharmacopeial specifications

Q7. Which documentation practice is a core requirement of GMP for traceability?

• Verbal approvals recorded in memory
• Complete batch manufacturing records, raw material lot numbers and distribution records
• Single master batch record used for all products with no changes
• Only final product labels archived

Correct Answer: Complete batch manufacturing records, raw material lot numbers and distribution records

Q8. In herbal cosmetic manufacturing, what is the main reason for a supplier qualification program?

• To negotiate lower prices only
• To verify suppliers consistently provide materials of required identity, quality and safety
• To limit the number of suppliers to one
• To allow immediate acceptance of all deliveries without testing

Correct Answer: To verify suppliers consistently provide materials of required identity, quality and safety

Q9. Which of the following microorganisms must be absent in eye-area cosmetic products as per typical microbial safety criteria?

• Escherichia coli
• Pseudomonas aeruginosa
• Bacillus subtilis
• Micrococcus luteus

Correct Answer: Pseudomonas aeruginosa

Q10. What is the most appropriate approach to control pesticide residues in herbal raw materials?

• Assume low risk and skip testing for every lot
• Implement supplier standards, perform risk-based residue testing and require certificates of analysis
• Rely only on supplier reputation
• Wash raw material only at manufacturing site

Correct Answer: Implement supplier standards, perform risk-based residue testing and require certificates of analysis

Q11. Which quality tool is commonly used in GMP for managing deviations, corrective and preventive actions?

• CAPA (Corrective and Preventive Action)
• Six Sigma only for marketing
• Inventory turnover ratio
• Gantt chart for production scheduling

Correct Answer: CAPA (Corrective and Preventive Action)

Q12. For herbal cosmetic stability studies, which condition is typically evaluated to support shelf-life claims?

• Only ambient temperature without humidity control
• Real-time and accelerated conditions (e.g., 25°C/60% RH and 40°C/75% RH) with periodic testing
• Freezing for 48 hours only
• Testing only after product expiry

Correct Answer: Real-time and accelerated conditions (e.g., 25°C/60% RH and 40°C/75% RH) with periodic testing

Q13. What is the role of environmental monitoring in the production area for herbal cosmetics?

• To replace finished product testing entirely
• To monitor airborne and surface contamination trends and verify cleaning and hygiene controls
• To audit suppliers’ financials
• To increase production speed

Correct Answer: To monitor airborne and surface contamination trends and verify cleaning and hygiene controls

Q14. Which labeling element is essential for herbal cosmetics to ensure consumer safety and regulatory compliance?

• Only brand logo without ingredient list
• Complete ingredient declaration using INCI names, usage instructions and warnings
• Unverified traditional claims without substantiation
• Manufacturing cost printed on label

Correct Answer: Complete ingredient declaration using INCI names, usage instructions and warnings

Q15. What is a key difference when applying GMP to herbal cosmetics versus synthetic cosmetics?

• Herbal products never require microbial testing
• Herbal cosmetics require additional focus on botanical identification, variability, residues and extract standardization
• Synthetic cosmetics have no regulatory oversight
• Herbal cosmetics do not require stability studies

Correct Answer: Herbal cosmetics require additional focus on botanical identification, variability, residues and extract standardization

Q16. Which practice helps prevent cross-contamination between different herbal products in a facility?

• Using the same equipment without cleaning between batches
• Logical scheduling, dedicated equipment or validated cleaning between product types and proper segregation
• Mixing raw materials in a common holding area
• Removing labels from containers after use

Correct Answer: Logical scheduling, dedicated equipment or validated cleaning between product types and proper segregation

Q17. Which test is commonly used to quantify heavy metal contamination in herbal raw materials?

• UV-Vis color comparison
• Atomic Absorption Spectroscopy (AAS) or ICP-MS
• pH paper strip
• Organoleptic assessment

Correct Answer: Atomic Absorption Spectroscopy (AAS) or ICP-MS

Q18. Under GMP, what is the importance of a change control system in herbal cosmetic manufacturing?

• To allow undocumented process alterations
• To formally assess, approve, document and communicate changes that may affect quality and compliance
• To postpone corrective actions indefinitely
• To censor audit findings

Correct Answer: To formally assess, approve, document and communicate changes that may affect quality and compliance

Q19. Which aspect is critical when validating an extraction process for herbal ingredients used in cosmetics?

• Only speed of extraction matters
• Demonstrating reproducible recovery of target actives, control of solvent residues and impurity profile
• Using unspecified solvents without testing
• Skipping analytical method validation

Correct Answer: Demonstrating reproducible recovery of target actives, control of solvent residues and impurity profile

Q20. What is the best practice for complaint handling under GMP for herbal cosmetics?

• Ignore complaints that cannot be immediately resolved
• Record, investigate root cause, implement corrective action, assess product safety risk and retain documentation for trend analysis
• Only respond with a sales discount
• Delete records after resolving the issue informally

Correct Answer: Record, investigate root cause, implement corrective action, assess product safety risk and retain documentation for trend analysis

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