SOPs, health and hygiene, documentation and records in herbal industry MCQs With Answer

Introduction

The herbal industry demands strict adherence to SOPs, health and hygiene, documentation, and records to ensure safe, consistent herbal medicines. For B.Pharm students, understanding Good Manufacturing Practices (GMP), Good Agricultural and Collection Practices (GACP), controlled documents, master batch records, traceability, and cleaning and sanitation SOPs is essential. Proper personnel hygiene, PPE use, training records, deviation management, and effective record-keeping (batch records, Certificates of Analysis, distribution and retention logs) reduce contamination and support regulatory compliance. This focused overview bridges theory and practice for quality assurance, production, and regulatory inspection readiness. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which primary purpose do SOPs serve in a herbal manufacturing facility?

• To replace regulatory inspections
• To standardize processes, ensure quality and reduce variability
• To market products to customers
• To set sales targets for production

Correct Answer: To standardize processes, ensure quality and reduce variability

Q2. What is the most appropriate document to record step-by-step instructions for a specific manufacturing operation?

• Master production formula
• Standard Operating Procedure (SOP)
• Certificate of Analysis (COA)
• Training record

Correct Answer: Standard Operating Procedure (SOP)

Q3. Which record best provides traceability from raw herb to finished product?

• Employee attendance sheet
• Packing slip
• Batch manufacturing record with raw material lot numbers
• Marketing brochures

Correct Answer: Batch manufacturing record with raw material lot numbers

Q4. What is a critical component of personnel health and hygiene in herbal production?

• Wearing jewelry during processing
• Regular handwashing and use of appropriate PPE
• Eating next to production lines
• Working while ill to meet deadlines

Correct Answer: Regular handwashing and use of appropriate PPE

Q5. Which practice helps prevent cross-contamination between different herbal batches?

• Using the same utensils without cleaning
• Segregated equipment, dedicated cleaning SOPs and scheduling
• Mixing batches intentionally
• Ignoring allergen control

Correct Answer: Segregated equipment, dedicated cleaning SOPs and scheduling

Q6. What should a deviation report document?

• The reason for noncompliance, impact assessment and corrective actions
• Only the name of the person involved
• Marketing plans for the product
• Payroll adjustments

Correct Answer: The reason for noncompliance, impact assessment and corrective actions

Q7. Which document typically contains the list of raw materials, quantities and manufacturing steps for a specific product?

• Master batch record (Master Formula)
• Training manual
• Client invoice
• Employee handbook

Correct Answer: Master batch record (Master Formula)

Q8. Why are retention samples kept in herbal manufacturing?

• For employee recreation
• To allow future testing in case of quality complaints or disputes
• To sell at a discount later
• To increase warehouse occupancy

Correct Answer: To allow future testing in case of quality complaints or disputes

Q9. Which of the following is a controlled document?

• SOP with version number and approval signature
• Loose notes on a desk
• Public website text without revision history
• Unapproved draft in personal email

Correct Answer: SOP with version number and approval signature

Q10. What is the role of Certificates of Analysis (COA) in herbal products?

• To certify the product’s marketing price
• To document analytical results that confirm identity and quality of raw materials or finished goods
• To record employee training
• To list retail outlets

Correct Answer: To document analytical results that confirm identity and quality of raw materials or finished goods

Q11. Which practice is essential during herbal material handling to maintain hygiene?

• Allowing outdoor shoes in processing area
• Using clean, dedicated PPE and controlled access to processing areas
• Not monitoring air quality
• Storing raw herbs on the floor

Correct Answer: Using clean, dedicated PPE and controlled access to processing areas

Q12. How often should SOPs be reviewed?

• Never once written
• Periodically and after significant process or regulatory changes
• Only when an employee leaves
• Every day without reason

Correct Answer: Periodically and after significant process or regulatory changes

Q13. What is the primary objective of Good Agricultural and Collection Practices (GACP) for medicinal plants?

• To increase sales only
• To ensure quality, purity and sustainable sourcing of raw plant materials
• To limit genetic diversity
• To eliminate paperwork

Correct Answer: To ensure quality, purity and sustainable sourcing of raw plant materials

Q14. Which record documents environmental monitoring data (e.g., temperature, humidity) in storage areas?

• Training log
• Environmental monitoring and storage condition logs
• Payroll ledger
• Promotional materials

Correct Answer: Environmental monitoring and storage condition logs

Q15. In documentation, what does “traceability” primarily allow?

• Tracking product from finished goods back to raw materials and suppliers
• Hiding sources of contamination
• Faster marketing campaigns
• Eliminating batch records

Correct Answer: Tracking product from finished goods back to raw materials and suppliers

Q16. Which is a best practice when an employee reports illness in a herbal production area?

• Allow them to continue work to avoid delays
• Exclude them from production until medically cleared to prevent contamination
• Ignore the report
• Let them handle quality control tasks while sick

Correct Answer: Exclude them from production until medically cleared to prevent contamination

Q17. What information is essential on a raw material receiving log?

• Supplier name, lot number, quantity received and visual condition
• The supplier’s marketing slogan
• Only the delivery driver’s name
• Future purchase plans

Correct Answer: Supplier name, lot number, quantity received and visual condition

Q18. Which action is part of a cleaning SOP for processing equipment?

• Using an unspecified cleaning agent without validation
• Specifying cleaning agents, contact time, method and verification steps
• Skipping rinsing steps
• Cleaning only when the equipment looks dirty

Correct Answer: Specifying cleaning agents, contact time, method and verification steps

Q19. What is the purpose of a master label or labeling control in herbal manufacturing?

• To allow unapproved label variations
• To define approved label content, claims, and artwork to prevent mislabeling
• To confuse distributors
• To delay product release

Correct Answer: To define approved label content, claims, and artwork to prevent mislabeling

Q20. Which record helps during a product recall?

• Distribution records with lot numbers and recipient details
• Employee social media posts
• Supplier marketing materials
• Unrelated financial reports

Correct Answer: Distribution records with lot numbers and recipient details

Q21. What is the role of training records in the herbal industry?

• To document that personnel received, understood and were qualified for assigned tasks
• To serve as promotional flyers
• To replace SOPs
• To record visitor names only

Correct Answer: To document that personnel received, understood and were qualified for assigned tasks

Q22. Which practice improves microbial control in processing areas?

• Regular sanitation, validated cleaning procedures, and controlled airflow
• Leaving windows open to outside without control
• Ignoring cleaning schedules
• Allowing eating in processing rooms

Correct Answer: Regular sanitation, validated cleaning procedures, and controlled airflow

Q23. Which of the following is an example of a quality record?

• Batch release certificate signed by quality unit
• Employee vacation request
• Office decor inventory
• Sales target spreadsheet

Correct Answer: Batch release certificate signed by quality unit

Q24. What should be included when approving a new or revised SOP?

• Approval signature, effective date and controlled version number
• Only the author’s initials without date
• An informal note on a sticky pad
• No review process

Correct Answer: Approval signature, effective date and controlled version number

Q25. During a GMP inspection, which documentation is most critical to demonstrate compliance?

• Batch records, SOPs, training logs, and deviation/CAPA records
• Marketing campaign calendars
• Employee personal letters
• Internal social event photos

Correct Answer: Batch records, SOPs, training logs, and deviation/CAPA records

Q26. What is the best immediate action if contamination is suspected in a batch?

• Continue processing to avoid delays
• Quarantine the affected batch and initiate investigation per SOP
• Mix it with another batch to dilute
• Dispose without documentation

Correct Answer: Quarantine the affected batch and initiate investigation per SOP

Q27. Which document defines roles, responsibilities and authorities for quality activities?

• Organizational chart and job descriptions
• Personal diary
• Customer complaint letter
• Supplier advertisement

Correct Answer: Organizational chart and job descriptions

Q28. Why is version control important for SOPs and templates?

• To allow multiple uncontrolled copies in circulation
• To ensure only the current approved procedures are used and previous versions are archived
• To confuse staff
• To delay training

Correct Answer: To ensure only the current approved procedures are used and previous versions are archived

Q29. Which item is typically part of hygiene monitoring for personnel?

• Microbial fingertip sampling, gowning logs and health declarations
• Only measuring hair length
• Tracking social media accounts
• Assessing commuting distance

Correct Answer: Microbial fingertip sampling, gowning logs and health declarations

Q30. What is an effective recordkeeping habit for quality assurance in herbal manufacturing?

• Timely, accurate entries with signatures, dates and legible records
• Making entries days later from memory
• Using erasable ink without controls
• Leaving records incomplete

Correct Answer: Timely, accurate entries with signatures, dates and legible records

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