Site Acceptance Test (SAT) MCQs With Answer

Site Acceptance Test (SAT) MCQs With Answer

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Site Acceptance Test (SAT) MCQs With Answer

Introduction: This quiz collection focuses on Site Acceptance Test (SAT) concepts and practices within pharmaceutical validation, tailored for M.Pharm students. SAT is a critical phase in equipment and system qualification performed at the user’s facility to confirm functionality, interfaces with utilities, safety interlocks, and compliance with user requirements in the actual operational environment. These MCQs cover objectives, protocol elements, test types, documentation, responsibilities, acceptance criteria, and relationships with FAT, IQ/OQ, and GMP. Practicing these questions will deepen your understanding of SAT planning, execution, deviation handling, and regulatory implications essential for successful commissioning and qualification of pharmaceutical systems.

Q1. What is the primary objective of a Site Acceptance Test (SAT)?

  • To verify equipment and system performance at the user’s site under actual operational conditions
  • To perform a visual inspection of equipment packaging before shipping
  • To replace factory acceptance testing (FAT) entirely
  • To certify staff competency for routine operations

Correct Answer: To verify equipment and system performance at the user’s site under actual operational conditions

Q2. When is SAT typically performed in the validation lifecycle?

  • After installation at site and usually following a successful FAT
  • Before FAT at the vendor’s manufacturing location
  • Only after final product release to the market
  • Simultaneously with routine production batches

Correct Answer: After installation at site and usually following a successful FAT

Q3. Which document typically outlines the tests, acceptance criteria, and responsibilities for SAT?

  • SAT Protocol
  • Change Control Request
  • Standard Operating Procedure for Production
  • Material Safety Data Sheet (MSDS)

Correct Answer: SAT Protocol

Q4. Which of the following is NOT normally verified during SAT?

  • Integration of equipment with site utilities and control systems
  • Functionality of alarms and interlocks
  • Product stability study under accelerated conditions
  • Electrical safety and local operator interface behavior

Correct Answer: Product stability study under accelerated conditions

Q5. What is the relationship between FAT and SAT?

  • FAT verifies functionality at vendor site; SAT verifies same functionality at user’s site under operational conditions
  • FAT and SAT are identical and performed at the same location
  • SAT replaces FAT and makes it unnecessary
  • FAT only applies to software while SAT applies only to hardware

Correct Answer: FAT verifies functionality at vendor site; SAT verifies same functionality at user’s site under operational conditions

Q6. Which test in SAT evaluates control software and PLC interactions with site systems?

  • Interface and control logic testing
  • Cleaning validation
  • Thermal mapping
  • Microbial limit test

Correct Answer: Interface and control logic testing

Q7. Which of the following should be completed before executing the SAT?

  • Successful completion of FAT and confirmation of installation/utility readiness
  • Final product stability testing
  • Routine batch manufacturing for commercial release
  • Regulatory inspection of the facility

Correct Answer: Successful completion of FAT and confirmation of installation/utility readiness

Q8. What is a common acceptance criterion used in SAT reports?

  • Measured values within pre-defined limits documented in the SAT protocol
  • Vendor’s subjective opinion of satisfactory performance
  • Any result obtained during the first test run regardless of specification
  • Completion of testing within the shortest possible time

Correct Answer: Measured values within pre-defined limits documented in the SAT protocol

Q9. Who typically signs off the SAT report as a final approver from the user side?

  • Qualified person or responsible validation/engineering representative
  • Shipping clerk from the vendor
  • Temporary contract labor supervising the test
  • External marketing manager

Correct Answer: Qualified person or responsible validation/engineering representative

Q10. Which of these elements is essential in SAT traceability?

  • Traceability matrix linking user requirements, test cases, and results
  • Only the vendor’s invoice number
  • Employee personal opinions recorded informally
  • Unstructured photographs without context

Correct Answer: Traceability matrix linking user requirements, test cases, and results

Q11. How should deviations discovered during SAT be handled?

  • Documented, investigated for impact, dispositioned, and included in final report
  • Ignored if the overall test time must be saved
  • Corrected immediately without documentation to avoid delays
  • Reported only to the vendor and not recorded in the site files

Correct Answer: Documented, investigated for impact, dispositioned, and included in final report

Q12. Which test would confirm cleaning-in-place (CIP) or sterilization-in-place (SIP) integration during SAT?

  • Operational challenge of CIP/SIP cycles including control sequencing and valves
  • Particle size analysis of the final product
  • Long-term accelerated stability testing
  • Personnel gowning competency test

Correct Answer: Operational challenge of CIP/SIP cycles including control sequencing and valves

Q13. Why is calibration status verification important during SAT?

  • To ensure instruments used in SAT produce traceable, accurate measurements
  • Calibration status is irrelevant for SAT measurements
  • To reduce paperwork required for commissioning
  • To permit indefinite use of non-calibrated instruments

Correct Answer: To ensure instruments used in SAT produce traceable, accurate measurements

Q14. Which of the following best describes a successful SAT outcome?

  • All planned tests meet acceptance criteria or documented deviations are accepted with appropriate CAPA
  • Tests completed regardless of meeting specified acceptance criteria
  • Vendor declares equipment operational without user verification
  • Only visual checks are documented without functional tests

Correct Answer: All planned tests meet acceptance criteria or documented deviations are accepted with appropriate CAPA

Q15. In a pharmaceutical SAT, what is the significance of environmental and utility conditions?

  • They must reflect operational conditions since they affect equipment performance and product quality
  • They can be ignored because equipment will adjust automatically
  • Utility conditions are only relevant during FAT at vendor site
  • Environmental conditions are only considered during regulatory inspections

Correct Answer: They must reflect operational conditions since they affect equipment performance and product quality

Q16. Which record should be archived as part of SAT documentation for GMP compliance?

  • Signed SAT protocol, raw data, deviation records, and final SAT report
  • Only the vendor’s promotional brochures
  • Personal emails between technicians without attachments
  • Unofficial handwritten notes not signed or dated

Correct Answer: Signed SAT protocol, raw data, deviation records, and final SAT report

Q17. What is the impact of SAT on subsequent IQ/OQ/PQ activities?

  • SAT confirms site-specific readiness and may be prerequisite or integrated with IQ/OQ/PQ sequencing
  • SAT replaces IQ/OQ/PQ entirely and no further validation is needed
  • SAT only affects procurement and has no technical relation to IQ/OQ/PQ
  • SAT is only performed after PQ and thus has no impact

Correct Answer: SAT confirms site-specific readiness and may be prerequisite or integrated with IQ/OQ/PQ sequencing

Q18. Which party is typically responsible for executing SAT tests that involve process utilities at the user site?

  • User site engineers in collaboration with vendor representatives
  • Only the vendor without user involvement
  • An external marketing consultant
  • Cleaning crew unrelated to validation

Correct Answer: User site engineers in collaboration with vendor representatives

Q19. How should software changes discovered necessary during SAT be managed?

  • Raised in change control, impact assessed, updated in design documents, and re-tested as per protocol
  • Implemented immediately without review to speed up testing
  • Ignored until after product launch
  • Noted in a notebook but not tracked formally

Correct Answer: Raised in change control, impact assessed, updated in design documents, and re-tested as per protocol

Q20. Which metric is important to include in SAT report summary for regulatory inspection readiness?

  • List of executed tests, pass/fail results, deviations and their dispositions, and signatures of responsible personnel
  • Estimated sales projections for equipment performance
  • Personal opinions of attendees without supporting data
  • Only photographs without the associated test data

Correct Answer: List of executed tests, pass/fail results, deviations and their dispositions, and signatures of responsible personnel

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