Food safety systems such as HACCP (Hazard Analysis and Critical Control Points) and GMP (Good Manufacturing Practices) are essential for B.Pharm students to ensure pharmaceutical and food-grade product safety. This introduction covers key concepts including hazard analysis, critical control points, prerequisite programs, verification, validation, documentation, sanitation, microbial control, risk assessment, corrective actions, traceability and regulatory compliance. Understanding HACCP principles and GMP requirements helps students design, implement and audit robust food safety and quality systems across manufacturing, packaging and distribution. Emphasis on monitoring, calibration, personnel hygiene and record-keeping links theory to practical pharmaceutical contexts. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of HACCP in food and pharmaceutical manufacturing?
- To minimize production costs
- To eliminate all microorganisms
- To identify and control critical points to prevent hazards
- To replace GMP requirements
Correct Answer: To identify and control critical points to prevent hazards
Q2. Which of the following is NOT one of the seven principles of HACCP?
- Conduct hazard analysis
- Establish critical limits
- Perform microbial sterilization of all products
- Establish monitoring procedures
Correct Answer: Perform microbial sterilization of all products
Q3. In HACCP, a Critical Control Point (CCP) is best defined as:
- A point where documents are stored
- A step at which control can be applied to prevent or eliminate a food safety hazard
- A location for employee training
- An administrative approval step
Correct Answer: A step at which control can be applied to prevent or eliminate a food safety hazard
Q4. Good Manufacturing Practices (GMP) primarily focus on:
- Marketing and sales processes
- Designing new products only
- Ensuring consistent product quality and safety through controls and documentation
- Inventory reduction strategies
Correct Answer: Ensuring consistent product quality and safety through controls and documentation
Q5. Which prerequisite program is most directly aimed at preventing cross-contamination from personnel?
- Pest control
- Personnel hygiene and training
- Equipment calibration
- Supply chain management
Correct Answer: Personnel hygiene and training
Q6. A critical limit in HACCP is:
- An economic threshold for production
- A measurable parameter (e.g., temperature, time) that separates safe from unsafe
- A marketing objective
- A personnel attendance goal
Correct Answer: A measurable parameter (e.g., temperature, time) that separates safe from unsafe
Q7. Which document is essential for proving that a GMP system is operating correctly over time?
- Marketing brochure
- Validated software license
- Comprehensive records and batch documentation
- Employee personal notes
Correct Answer: Comprehensive records and batch documentation
Q8. What is the role of verification in HACCP systems?
- To approve marketing campaigns
- To confirm that HACCP plans are functioning as intended through testing and audits
- To replace monitoring procedures
- To perform staff appraisals
Correct Answer: To confirm that HACCP plans are functioning as intended through testing and audits
Q9. Which hazard category does a chemical residue (e.g., pesticide) belong to?
- Biological hazard
- Physical hazard
- Chemical hazard
- Environmental hazard
Correct Answer: Chemical hazard
Q10. Which tool is commonly used to identify CCPs during HACCP planning?
- Control chart
- Decision tree (CCP decision tree)
- Pareto chart
- SWOT analysis
Correct Answer: Decision tree (CCP decision tree)
Q11. What is a prerequisite program (PRP) in the context of food safety?
- A marketing plan for new products
- Basic environmental and operational conditions necessary for HACCP to be effective
- A financial audit
- An external certification only
Correct Answer: Basic environmental and operational conditions necessary for HACCP to be effective
Q12. In GMP, validation refers to:
- Ensuring equipment is clean
- Providing documented evidence that a process consistently produces a result meeting predetermined specifications
- Staff training schedules
- Labeling artwork approval
Correct Answer: Providing documented evidence that a process consistently produces a result meeting predetermined specifications
Q13. Which of the following is an example of a physical hazard?
- Salmonella contamination
- Glass shard in a tablet
- Pesticide residue
- Allergen cross-contact
Correct Answer: Glass shard in a tablet
Q14. What is the primary reason for calibration of instruments in GMP and HACCP programs?
- To increase energy efficiency
- To ensure measurement accuracy for monitoring critical parameters
- To extend equipment warranty
- To improve staff productivity
Correct Answer: To ensure measurement accuracy for monitoring critical parameters
Q15. Corrective actions in HACCP are required when:
- A CCP monitoring result shows deviation from critical limits
- A new product is launched
- Staff requests a change
- Marketing updates labeling
Correct Answer: A CCP monitoring result shows deviation from critical limits
Q16. Traceability in GMP/HACCP systems primarily allows you to:
- Track the marketing performance of a product
- Trace raw materials and finished products through supply chain for recall or investigation
- Monitor employee attendance
- Forecast sales
Correct Answer: Trace raw materials and finished products through supply chain for recall or investigation
Q17. During hazard analysis, which factor is used to prioritize hazards?
- Supplier location
- Severity and likelihood of occurrence
- Employee preference
- Brand reputation
Correct Answer: Severity and likelihood of occurrence
Q18. Which GMP element addresses building design, flow of personnel, and material movement to prevent contamination?
- Sanitation record-keeping
- Facility layout and hygiene design
- Marketing strategy
- Financial control
Correct Answer: Facility layout and hygiene design
Q19. The purpose of a flow diagram in HACCP plan development is to:
- Provide a marketing map for distribution
- Visually describe each step in the process to identify hazards and CCPs
- Document employee roles
- Record financial transactions
Correct Answer: Visually describe each step in the process to identify hazards and CCPs
Q20. Which of the following is a common verification activity in GMP audits?
- Color choice for packaging
- Review of calibration certificates and validation reports
- Setting sales targets
- Designing new labels
Correct Answer: Review of calibration certificates and validation reports
Q21. Which microorganism type is most commonly associated with foodborne illness relevant to HACCP?
- Viruses like Norovirus and bacteria like Salmonella
- Fungi used in fermentation only
- Plant viruses
- Inert environmental microbes with no pathogenicity
Correct Answer: Viruses like Norovirus and bacteria like Salmonella
Q22. What is the significance of establishing monitoring procedures at a CCP?
- To create marketing metrics
- To allow continuous verification that control measures are within critical limits
- To train staff on communication
- To track inventory levels
Correct Answer: To allow continuous verification that control measures are within critical limits
Q23. Which action is part of good sanitation practice under GMP?
- Ignoring cleaning schedules when busy
- Using validated cleaning procedures and documented records
- Allowing visitors into production without restriction
- Storing chemicals near product lines
Correct Answer: Using validated cleaning procedures and documented records
Q24. How does risk assessment contribute to HACCP and GMP?
- It sets marketing priorities
- It evaluates the probability and impact of hazards to prioritize controls
- It schedules employee vacations
- It establishes pricing models
Correct Answer: It evaluates the probability and impact of hazards to prioritize controls
Q25. Which of the following best distinguishes a CCP from a simple control point?
- CCP is optional; control point is mandatory
- CCP is a step where loss of control could result in unacceptable risk to safety
- Control point always involves physical hazards only
- CCP relates only to packaging aesthetics
Correct Answer: CCP is a step where loss of control could result in unacceptable risk to safety
Q26. In a HACCP plan, who should ideally be part of the HACCP team?
- Only senior management
- Multidisciplinary members including quality, production, engineering, and microbiology experts
- Only sales personnel
- External marketing consultants only
Correct Answer: Multidisciplinary members including quality, production, engineering, and microbiology experts
Q27. Which record is most useful during a product recall to identify affected batches?
- Batch production records with lot numbers and ingredient traceability
- Employee attendance logs
- General company brochure
- Annual profit and loss statement
Correct Answer: Batch production records with lot numbers and ingredient traceability
Q28. What does “validation of cleaning procedures” demonstrate?
- That cleaning is faster than before
- That cleaning consistently achieves defined cleanliness criteria reducing contamination risk
- That fewer staff are required
- That production output increases
Correct Answer: That cleaning consistently achieves defined cleanliness criteria reducing contamination risk
Q29. Which factor is critical when establishing a microbiological sampling plan under HACCP?
- Sampling frequency, sample size and representative sampling locations
- Marketing preferences
- Color of sampling containers only
- Employee age
Correct Answer: Sampling frequency, sample size and representative sampling locations
Q30. How often should a HACCP plan be reviewed and updated?
- Only once when first written
- Whenever changes occur in process, ingredients, equipment, or when verification indicates deficiencies
- Never, to maintain consistency
- Only when requested by customers
Correct Answer: Whenever changes occur in process, ingredients, equipment, or when verification indicates deficiencies
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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