Pharmaceutical Quality System (PQS)
Questions 1. The manufacture of sterile products requires:
A. Minimal controls
B. Specific controls and measures
C. Only visual inspection
D. No specialized systems
Answer: B
Questions 2. The primary goal of the PQS for sterile products is to:
A. Increase production speed
B. Minimize microbial, particulate, and endotoxin/pyrogen contamination
C. Reduce documentation
D. Eliminate the need for validation
Answer: B
Questions 3. The PQS for sterile products must comply with:
A. GDP guidelines only
B. Chapter 1 of GMP guidelines (Part I) plus specific sterile requirements
C. Local warehouse rules
D. Only industry best practices
Answer: B
Questions 4. An effective risk management system should aim to:
A. Increase testing
B. Minimize microbial contamination
C. Reduce process automation
D. Eliminate all human intervention
Answer: B
Questions 5. Manufacturers must have sufficient knowledge and expertise about:
A. Only laboratory testing
B. Products, equipment, engineering, and manufacturing methods
C. Regulatory affairs only
D. Marketing strategies
Answer: B
Questions 6. Root cause analysis should ensure:
A. That the process is sped up
B. Risks to the product are correctly identified and understood
C. Only equipment-related issues are reviewed
D. CAPA is optional
Answer: B
Questions 7. CAPA must be implemented following:
A. Any minor typo
B. Identified root causes of failures
C. Annual reviews only
D. Customer complaints only
Answer: B
Questions 8. Risk management in CCS must be:
A. Undocumented
B. Performed informally
C. Documented with rationale for decisions
D. Outsourced entirely
Answer: C
Questions 9. Senior management must:
A. Delegate all oversight
B. Oversee the state of control throughout the facility and product lifecycle
C. Avoid involvement in technical quality matters
D. Only review financial reports
Answer: B
Questions 10. Risk management outcomes should be reviewed:
A. Only during audits
B. Every five years
C. Regularly and during significant changes or problems
D. Only if the regulator requests it
Answer: C
Questions 11. Finished sterile products must be stored and transported:
A. In any convenient conditions
B. Under registered storage conditions
C. At room temperature only
D. Without temperature monitoring
Answer: B
Questions 12. Storage and transport processes should ensure:
A. Container integrity is preserved
B. Containers may be opened freely
C. Degradation is acceptable
D. Products do not need protection
Answer: A
Questions 13. Persons responsible for certification/release must have:
A. Marketing experience
B. Adequate knowledge and experience in sterile product manufacture
C. Packaging experience only
D. No need for access to manufacturing info
Answer: B
Questions 14. Certifiers/releasers must determine if products:
A. Are profitable
B. Match registered specifications and approved processes
C. Have attractive packaging
D. Meet customer expectations
Answer: B
Questions 15. Non-conformities must be:
A. Ignored if minor
B. Investigated adequately before batch release
C. Investigated only after certification
D. Dismissed if no complaint is filed
Answer: B
Questions 16. Examples of non-conformities include:
A. Marketing errors
B. Sterility test failures and EM excursions
C. Staff vacation days
D. High manufacturing cost
Answer: B
Questions 17. Investigation of non-conformities should determine:
A. Whether operators followed their break schedule
B. The potential impact on process and product quality
C. Financial loss
D. Customer satisfaction
Answer: B
Questions 18. Investigations must determine whether:
A. Other processes or batches might also be impacted
B. The batch is too expensive
C. The documentation style needs improvement
D. More marketing is required
Answer: A
Questions 19. Inclusion or exclusion of a batch from investigation must be:
A. Decided informally
B. Based on personal judgment
C. Clearly justified and recorded
D. Optional
Answer: C
Questions 20. The CCS should be maintained using:
A. Marketing strategies
B. Risk management
C. Product pricing
D. Supplier preferences
Answer: B
Questions 21. The risk management system should be integrated:
A. Only during manufacturing
B. Across all areas of the product lifecycle
C. Only during design
D. Only during packaging
Answer: B
Questions 22. Residual risk acceptance must be:
A. Avoided
B. Arbitrary
C. Documented and justified
D. Performed only annually
Answer: C
Questions 23. Senior management’s oversight includes:
A. Scheduling operator breaks
B. Ensuring a state of control
C. Designing product logos
D. Approving marketing campaigns
Answer: B
Questions 24. Risk management reviews should occur:
A. Only when operators request
B. During change control events
C. Only at product launch
D. Only after product recall
Answer: B
Questions 25. Transport conditions should ensure:
A. Protection from degradation
B. That costs remain low
C. Warehouse space is maximized
D. Products are exposed to ambient air
Answer: A
Questions 26. Certification personnel must have access to:
A. Only financial data
B. Manufacturing and quality information
C. Patent information only
D. Staff performance reviews
Answer: B
Questions 27. Lack of proper investigation before batch release may lead to:
A. Market success
B. Release of compromised products
C. Reduced validation requirements
D. Improved profitability
Answer: B
Questions 28. Sterility test failures should be:
A. Ignored if rare
B. Considered a non-conformity
C. Retested without documentation
D. Treated as acceptable
Answer: B
Questions 29. Environmental monitoring excursions require:
A. Immediate product shipment
B. Adequate investigation
C. No action
D. Delay until next review cycle
Answer: B
Questions 30. The overall purpose of the PQS for sterile products is to:
A. Increase marketing opportunities
B. Enhance visual appearance
C. Ensure quality and prevent contamination
D. Reduce manufacturing documentation
Answer: C