How to write and maintain Standard Operating Procedures (SOPs) MCQs With Answer

Introduction: Standard Operating Procedures (SOPs) are the backbone of consistent, compliant pharmaceutical operations. For M.Pharm students specializing in Quality Control and Quality Assurance, understanding how to write, implement, maintain, and revise SOPs is essential for ensuring product quality and regulatory compliance. This blog-style MCQ set focuses on practical principles—SOP structure, version control, change management, training, deviation handling, archival, and electronic document systems—emphasizing real-world GMP expectations. Questions are designed to deepen your conceptual grasp and application skills so you can draft clear SOPs, manage their lifecycle effectively, and support quality systems in both QC laboratories and production environments.

Q1. Which element is essential at the top of every SOP to immediately identify its status and applicability?

• Purpose statement
• Header with title, SOP number, version, and effective date
• Detailed procedure steps
• References and appendices

Correct Answer: Header with title, SOP number, version, and effective date

Q2. The primary purpose of an SOP is to:

• Replace training programs entirely
• Provide a legally binding contract
• Ensure consistent performance of a specific task and compliance with regulations
• Serve as promotional material for the company

Correct Answer: Ensure consistent performance of a specific task and compliance with regulations

Q3. Which section of an SOP explains the limits of where and when the document applies?

• Scope
• Procedure
• Responsibilities
• Record retention

Correct Answer: Scope

Q4. Best practice for numbering SOP versions typically includes which information?

• Only the year of creation
• Sequential version numbers or revision codes plus effective dates
• Employee ID of the author
• Number of pages in the SOP

Correct Answer: Sequential version numbers or revision codes plus effective dates

Q5. Who is normally responsible for final approval of an SOP in a GMP environment?

• Any operator on the shop floor
• Quality Assurance (QA) head or designated QA approver
• The procurement manager
• The external auditor

Correct Answer: Quality Assurance (QA) head or designated QA approver

Q6. How often should SOPs be reviewed at minimum to ensure continued relevance and compliance?

• Only when a deviation occurs
• Annually or according to company-defined periodic review intervals
• Every 10 years
• Never, once approved

Correct Answer: Annually or according to company-defined periodic review intervals

Q7. What is the main advantage of using a controlled SOP template across an organization?

• Increases variability between documents
• Ensures consistent layout, required sections and easier review
• Removes need for approvals
• Makes SOPs longer and more complex

Correct Answer: Ensures consistent layout, required sections and easier review

Q8. When an SOP is updated, what is the correct practice for superseded versions?

• Delete them permanently without record
• Keep superseded versions archived with version history and reason for change
• Leave them in circulation alongside the new version
• Give them a new number and reuse

Correct Answer: Keep superseded versions archived with version history and reason for change

Q9. What is the purpose of a “controlled copy” system for SOP distribution?

• To allow anyone to edit the SOP locally
• To ensure each holder has an authorized, current copy and traceability of distribution
• To publish SOPs on public websites
• To reduce the number of SOPs in the organization

Correct Answer: To ensure each holder has an authorized, current copy and traceability of distribution

Q10. Which practice supports effective training after SOP issuance or revision?

• Assuming staff will read the SOP in their spare time
• Formal training sessions, documented competence checks and training records
• Only informing management about the change
• Replacing SOP training with an email announcement

Correct Answer: Formal training sessions, documented competence checks and training records

Q11. In QC laboratories, an SOP for sampling should primarily address:

• How to market the sample to clients
• Sample identification, handling, chain of custody and acceptance criteria
• Payroll procedures for analysts
• How to dispose of unrelated waste

Correct Answer: Sample identification, handling, chain of custody and acceptance criteria

Q12. Which of the following best describes “change control” related to SOPs?

• A casual email to staff about a new procedure
• A formal documented process to evaluate, approve and implement changes with impact assessment
• Immediate implementation without review
• A policy to freeze all documents forever

Correct Answer: A formal documented process to evaluate, approve and implement changes with impact assessment

Q13. How should deviations from an SOP be handled?

• Ignore them if the result looks acceptable
• Record deviation, investigate root cause, initiate corrective actions and update SOP if needed
• Fire the personnel involved immediately
• Rewrite the SOP to match the deviation without analysis

Correct Answer: Record deviation, investigate root cause, initiate corrective actions and update SOP if needed

Q14. For electronic SOP systems, which attribute is critical to meet regulatory expectations?

• Editable by all employees at all times
• Audit trail, access control, version control and electronic signatures
• No backup or disaster recovery
• No password protection

Correct Answer: Audit trail, access control, version control and electronic signatures

Q15. Which statement about SOP language and format is most appropriate?

• Use long paragraphs and passive voice to sound authoritative
• Use clear, concise language, active voice, stepwise instructions and checklists where applicable
• Include unrelated company history to fill pages
• Keep instructions intentionally vague

Correct Answer: Use clear, concise language, active voice, stepwise instructions and checklists where applicable

Q16. What should be included in the responsibilities section of an SOP?

• Only the author’s biographical details
• Specific roles and duties of personnel related to the procedure, including QA oversight
• Financial budgets for the department
• Customer testimonials

Correct Answer: Specific roles and duties of personnel related to the procedure, including QA oversight

Q17. Which is a valid metric to evaluate the effectiveness of SOP implementation?

• Number of colors used in the SOP template
• Training completion rates, number of deviations related to the SOP and audit findings trend
• Length of the SOP in pages
• Salary of the SOP author

Correct Answer: Training completion rates, number of deviations related to the SOP and audit findings trend

Q18. When integrating SOPs across departments (e.g., QC and Production), what is essential?

• Each department writes completely independent SOPs with conflicting instructions
• Harmonization, clear interfaces, cross-references and joint approvals where activities overlap
• Removal of QA from the review process
• Keeping SOPs secret between departments

Correct Answer: Harmonization, clear interfaces, cross-references and joint approvals where activities overlap

Q19. Which describes an acceptable retention practice for SOP-associated records in a pharmaceutical company?

• Destroy all records after one month
• Retain records according to regulatory requirements and company policy, with controlled access and archival system
• Store records only on analysts’ personal devices
• No retention is required if SOPs exist

Correct Answer: Retain records according to regulatory requirements and company policy, with controlled access and archival system

Q20. What is the role of risk assessment when creating or revising an SOP?

• Risk assessment is irrelevant to SOPs
• Identify potential quality, safety or compliance risks and define controls or monitoring within the SOP
• Ensure the SOP increases product variability
• Replace the need for training

Correct Answer: Identify potential quality, safety or compliance risks and define controls or monitoring within the SOP

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