Standard Operating Procedures (SOPs) are essential documents in pharmaceutics that define step-by-step instructions for preparation and maintenance of laboratory and production activities. This introduction covers SOP writing, version control, document approval, change control, training, retention, archiving, deviation handling, CAPA, calibration, validation, and Good Manufacturing Practices (GMP) compliance—key topics for B. Pharm students. Clear, well-maintained SOPs ensure consistent product quality, safety, regulatory compliance, and effective quality assurance. Familiarity with SOP preparation and maintenance helps you avoid errors, manage audits, and support documentation integrity. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a Standard Operating Procedure (SOP) in a pharmaceutical laboratory?
- To provide a legal contract between staff
- To outline step-by-step instructions ensuring consistent and reproducible operations
- To replace batch records completely
- To list employee salaries and shifts
Correct Answer: To outline step-by-step instructions ensuring consistent and reproducible operations
Q2. Which of the following is an essential element that must appear in every SOP?
- Personal contact details of all staff
- Objective and scope
- Company marketing strategy
- Detailed financial budget
Correct Answer: Objective and scope
Q3. Where should the revision history/version control information be located in an SOP?
- At the end of the document only
- Only in the Quality Assurance computer system
- Prominently on the cover page or header/footer with dates and revision numbers
- Written on a sticky note attached to the SOP
Correct Answer: Prominently on the cover page or header/footer with dates and revision numbers
Q4. Who is typically responsible for approving and releasing an SOP in a GMP environment?
- The junior laboratory technician
- Quality Assurance or designated approver with authority
- External auditors only
- Any employee who wrote the SOP
Correct Answer: Quality Assurance or designated approver with authority
Q5. How often should SOPs be reviewed under routine document control practice?
- Only when a regulatory inspection occurs
- Periodically as defined by document control policy, commonly annually or biennially
- Never, once written they remain unchanged
- Every week regardless of content
Correct Answer: Periodically as defined by document control policy, commonly annually or biennially
Q6. What is a controlled copy of an SOP?
- An unofficial photocopy for personal use
- The only authorized, current version distributed to users with record of recipients
- An SOP stored on a personal laptop
- An SOP draft awaiting approval
Correct Answer: The only authorized, current version distributed to users with record of recipients
Q7. Which document change method is appropriate for updating an SOP that affects critical testing steps?
- Handwriting changes on the master copy without record
- Implementing changes through formal change control with risk assessment and approval
- Asking the operator to remember the new step verbally
- Posting the change on the notice board only
Correct Answer: Implementing changes through formal change control with risk assessment and approval
Q8. What must be documented after training staff on a new or revised SOP?
- Only the date of hiring
- Training records showing who was trained, date, trainer, and competency assessment
- Employees’ salaries
- Irrelevant personal notes
Correct Answer: Training records showing who was trained, date, trainer, and competency assessment
Q9. Which action is correct when an SOP is superseded by a new version?
- Destroy all records and proceed without documentation
- Archive the superseded version as controlled archive and replace controlled copies with new version
- Keep both versions in daily use without distinction
- Ignore the new version until an inspection
Correct Answer: Archive the superseded version as controlled archive and replace controlled copies with new version
Q10. What information defines the “effective date” of an SOP?
- The date it was first drafted
- The date the document becomes valid for use after approval and release
- The auditor’s visit date
- The expiration date of laboratory reagents
Correct Answer: The date the document becomes valid for use after approval and release
Q11. How should deviations from SOP procedures be managed?
- Ignore deviations if the result looks acceptable
- Document the deviation, investigate root cause, and implement corrective actions (CAPA) if needed
- Only inform colleagues verbally
- Destroy the affected product immediately without record
Correct Answer: Document the deviation, investigate root cause, and implement corrective actions (CAPA) if needed
Q12. Which of these is a critical requirement for electronic SOP systems?
- No user login required to speed access
- Audit trail, access control, and electronic signatures compliant with regulations
- Storage on a public website
- Editable by anyone without approval
Correct Answer: Audit trail, access control, and electronic signatures compliant with regulations
Q13. What is the role of SOPs in equipment qualification and calibration?
- SOPs are not used for equipment activities
- SOPs provide standardized procedures for installation, operational checks, calibration, and maintenance
- Only verbal instructions are acceptable for calibration
- Calibration should be random and undocumented
Correct Answer: SOPs provide standardized procedures for installation, operational checks, calibration, and maintenance
Q14. Which section of an SOP should list reference documents, forms, and related SOPs?
- Procedure steps
- References or bibliography section
- Signature block only
- Header with page numbers
Correct Answer: References or bibliography section
Q15. When writing an SOP, why is defining responsibilities important?
- Responsibilities are irrelevant to procedure
- To clearly assign accountability for performing, reviewing, and approving steps to specific roles
- To allow any staff member to interpret tasks freely
- To delay implementation indefinitely
Correct Answer: To clearly assign accountability for performing, reviewing, and approving steps to specific roles
Q16. What is a best practice for formatting SOP procedural steps?
- Use long paragraphs without numbering
- Use clear numbered steps, bullet points, and diagrams where needed for reproducibility
- Leave steps ambiguous for flexibility
- Include unrelated company slogans between steps
Correct Answer: Use clear numbered steps, bullet points, and diagrams where needed for reproducibility
Q17. For critical analytical methods, what must the SOP include regarding acceptance criteria?
- No acceptance criteria are needed
- Explicit acceptance criteria, limits, and references to validation data
- Only the analyst’s opinion
- Acceptance criteria from a competitor
Correct Answer: Explicit acceptance criteria, limits, and references to validation data
Q18. What is the appropriate retention period for SOPs and related records?
- Follow regulatory and company policy; often for the product lifecycle plus specified years
- Delete after one week
- Keep them only until next audit
- Keep indefinitely without index
Correct Answer: Follow regulatory and company policy; often for the product lifecycle plus specified years
Q19. How should confidential or restricted SOPs be controlled?
- Make them publicly available
- Restrict access through controlled distribution lists and access permissions
- Keep copies on employee desktops
- Allow anyone to request a printed copy at reception
Correct Answer: Restrict access through controlled distribution lists and access permissions
Q20. Which of the following best describes a “temporary deviation” to an SOP?
- A permanent rewrite of the SOP
- A documented, approved short-term allowance with defined conditions and duration
- An undocumented shortcut taken by staff
- A change that requires no approval
Correct Answer: A documented, approved short-term allowance with defined conditions and duration
Q21. Why are diagrams and flowcharts valuable in SOPs?
- They make the document longer for auditors
- They visually clarify complex workflows and reduce ambiguity
- They replace the need for any text
- They are decorative and optional for compliance
Correct Answer: They visually clarify complex workflows and reduce ambiguity
Q22. What should be included in the header or footer of each SOP page?
- Employee home addresses
- Document title, revision number, page number, and effective date
- Random motivational quotes
- Confidential salary information
Correct Answer: Document title, revision number, page number, and effective date
Q23. Who is responsible for routine maintenance of SOPs (updates, distribution, archiving)?
- Only external contractors
- Designated document owner or process owner with support from Quality Assurance
- All employees equally without assignment
- Only the company CEO
Correct Answer: Designated document owner or process owner with support from Quality Assurance
Q24. In the event of a regulatory inspection, what document control feature will inspectors commonly verify?
- Whether the SOP font color is aesthetically pleasing
- Presence of current controlled SOPs, revision history, approvals, and training records
- If SOPs are printed on glossy paper
- Personal opinions of staff about the SOP
Correct Answer: Presence of current controlled SOPs, revision history, approvals, and training records
Q25. What is the correct way to correct a minor handwritten error on a controlled paper SOP in use?
- Use white-out and rewrite without initialing
- Strike through error with a single line, write correction, initial, and date; or refer to current controlled version policies
- Completely rewrite the entire SOP immediately
- Ignore the error
Correct Answer: Strike through error with a single line, write correction, initial, and date; or refer to current controlled version policies
Q26. How should SOPs interact with validation documents?
- SOPs should be independent and ignore validation requirements
- SOPs should reference validated methods and include steps consistent with validation protocols
- Validation can be verbal and separate from SOPs
- SOPs invalidate validation reports
Correct Answer: SOPs should reference validated methods and include steps consistent with validation protocols
Q27. What is an important consideration when drafting SOP language for B. Pharm students or new staff?
- Use highly technical jargon without explanation
- Use clear, simple language with defined technical terms and examples for training
- Assume all readers have decades of experience
- Exclude safety instructions to shorten the document
Correct Answer: Use clear, simple language with defined technical terms and examples for training
Q28. Which record demonstrates that an employee is authorized to perform a specific SOP task?
- Employee cafeteria receipt
- Training and competency record related to that SOP
- Personal email signature
- Generic company ID card only
Correct Answer: Training and competency record related to that SOP
Q29. What is the purpose of an audit trail associated with SOP-controlled electronic records?
- To hide changes from auditors
- To provide a chronological record of who made changes, when, and why
- To slow down the system intentionally
- To store random unrelated data
Correct Answer: To provide a chronological record of who made changes, when, and why
Q30. Which practice best ensures ongoing compliance of SOPs after implementation?
- Never reviewing SOPs again once implemented
- Periodic review, training refreshers, internal audits, and CAPA for identified issues
- Relying on memory of senior staff only
- Disallowing access to SOPs to minimize changes
Correct Answer: Periodic review, training refreshers, internal audits, and CAPA for identified issues
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.
Mail- Sachin@pharmacyfreak.com