GALP requirements and SOPs MCQs With Answer

Introduction:

This quiz set on GALP requirements and SOPs is designed for M.Pharm students to deepen their practical understanding of Good Analytical Laboratory Practices within a regulated pharmaceutical environment. The questions cover essential elements such as laboratory organization, documentation, method validation, equipment calibration, data integrity (ALCOA+), deviation handling, and the structure and maintenance of Standard Operating Procedures (SOPs). Emphasis is placed on real-world application: preparing for inspections, implementing corrective and preventive actions, and ensuring reliable analytical results. Use these MCQs to reinforce theoretical knowledge, identify gaps, and prepare for university exams or regulatory audit scenarios.

Q1. Which of the following best describes the primary purpose of implementing GALP in an analytical laboratory?

• To reduce laboratory operational costs regardless of data quality
• To ensure reproducible, reliable analytical results and regulatory compliance
• To maximize sample throughput at the expense of documentation
• To allow informal practices that speed up analysis

Correct Answer: To ensure reproducible, reliable analytical results and regulatory compliance

Q2. Which element is essential in an SOP to ensure consistent execution of a critical analytical method?

• Historical anecdotes about the method developer
• Stepwise, unambiguous procedural instructions and acceptance criteria
• Only the name of the analyst responsible
• Vague guidance to allow analyst discretion

Correct Answer: Stepwise, unambiguous procedural instructions and acceptance criteria

Q3. In GALP, the acronym ALCOA+ refers to data integrity attributes. Which of the following is NOT part of ALCOA+?

• Attributable
• Legible
• Contemporaneous
• Anonymous

Correct Answer: Anonymous

Q4. Which practice is most appropriate when a deviation from an SOP occurs during an analysis?

• Ignore the deviation and file results as usual
• Record the deviation, investigate cause, assess impact, and implement corrective action
• Discard all data without documentation
• Modify results to match expected values

Correct Answer: Record the deviation, investigate cause, assess impact, and implement corrective action

Q5. What is the primary objective of equipment qualification under GALP?

• To increase the resale value of instruments
• To demonstrate that equipment operates within specified limits for intended use
• To ensure instruments are aesthetically pleasing
• To allow unqualified personnel to operate complex instruments

Correct Answer: To demonstrate that equipment operates within specified limits for intended use

Q6. Which of the following records should be retained to demonstrate traceability of sample analysis?

• Only the final report, without raw data
• Sample receipt logs, chain of custody, raw data, and final reports
• Just the analyst’s signed summary
• Photocopies of unrelated invoices

Correct Answer: Sample receipt logs, chain of custody, raw data, and final reports

Q7. When writing an SOP revision history, which information is critical to include?

• Date of revision, reason for change, summary of changes, and authorizing signature
• Only the date of the original SOP
• The name of the person who printed the SOP
• The number of pages in the SOP without details

Correct Answer: Date of revision, reason for change, summary of changes, and authorizing signature

Q8. Which audit type focuses on an independent review of laboratory processes to verify compliance to GALP and SOPs?

• Internal audit performed by the same department only
• Regulatory inspection or third-party compliance audit
• Informal peer discussion
• Customer feedback without documentation

Correct Answer: Regulatory inspection or third-party compliance audit

Q9. What is the correct action when an SOP no longer reflects current practice due to a validated procedural improvement?

• Continue following the old SOP silently
• Update the SOP with explanation, approval, and effective date after validation
• Delete the SOP without record
• Let each analyst apply the improvement without documenting it

Correct Answer: Update the SOP with explanation, approval, and effective date after validation

Q10. Which parameter is NOT typically part of analytical method validation under GALP?

• Accuracy
• Precision
• Taste
• Specificity

Correct Answer: Taste

Q11. How should training records be maintained to satisfy GALP requirements?

• Informal notes kept only by the trainer
• Documented records showing training content, date, trainer, and trainee signatures
• Verbal confirmation without signatures
• Only a list of employee names without topics

Correct Answer: Documented records showing training content, date, trainer, and trainee signatures

Q12. Which of the following best describes the role of a Quality Assurance (QA) unit in a GALP-compliant lab?

• To perform all routine analyses
• To provide independent oversight, approve SOPs, audits, and ensure compliance
• To handle only procurement of consumables
• To supervise cafeteria services

Correct Answer: To provide independent oversight, approve SOPs, audits, and ensure compliance

Q13. What is the importance of change control in GALP?

• To permit uncontrolled changes when convenient
• To evaluate, document, and approve changes to processes or equipment to prevent unintended consequences
• To allow managers to bypass validation
• To archive obsolete records without review

Correct Answer: To evaluate, document, and approve changes to processes or equipment to prevent unintended consequences

Q14. Which practice helps to ensure data authenticity in computerized systems used in a GALP environment?

• Shared generic logins without audit trails
• Use of unique user accounts, access controls, and secure audit trails
• Disabling electronic signatures
• Storing data on personal USB drives without backup

Correct Answer: Use of unique user accounts, access controls, and secure audit trails

Q15. Which statement about SOP distribution and access is correct under GALP?

• SOPs should be freely editable by all staff
• Current controlled copies of SOPs must be available to all relevant personnel while obsolete versions are archived
• SOPs should be kept secret and unavailable to analysts
• SOPs should only exist in the memory of senior staff

Correct Answer: Current controlled copies of SOPs must be available to all relevant personnel while obsolete versions are archived

Q16. What is a primary objective of environmental controls (temperature, humidity) in analytical labs under GALP?

• To create comfortable conditions for visitors only
• To maintain conditions that prevent sample degradation and ensure instrument performance
• To reduce electricity usage at the cost of data quality
• To allow fluctuating conditions for method robustness testing

Correct Answer: To maintain conditions that prevent sample degradation and ensure instrument performance

Q17. Which document typically defines roles, responsibilities, and reporting lines for laboratory personnel in GALP?

• Employee cafeteria menu
• Organizational chart and job descriptions
• Raw instrument manuals only
• Personal notebooks of staff

Correct Answer: Organizational chart and job descriptions

Q18. During a regulatory inspection, which behavior by laboratory staff best demonstrates GALP compliance?

• Being evasive and withholding records
• Providing accurate, complete records and cooperating with inspectors
• Destroying questionable records to avoid findings
• Refusing to answer questions without management present

Correct Answer: Providing accurate, complete records and cooperating with inspectors

Q19. What is the recommended approach for archival of analytical raw data under GALP?

• Store raw data in a secure, backed-up system with controlled access and defined retention periods
• Keep raw data on a single analyst’s personal computer
• Print everything and discard electronic copies immediately
• Retain only summary reports and delete raw traces

Correct Answer: Store raw data in a secure, backed-up system with controlled access and defined retention periods

Q20. Which aspect is critical when developing an SOP for sample handling to prevent cross-contamination?

• Allowing multiple sample types to be processed together without cleaning
• Clear instructions on sample segregation, cleaning procedures, dedicated consumables, and verification steps
• Using the same glassware for all samples without washing
• Relying on analyst memory for cleaning intervals

Correct Answer: Clear instructions on sample segregation, cleaning procedures, dedicated consumables, and verification steps

Download