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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 2: GMP Regulations and Compliance | - Regulatory frameworks
|
| Topic 3: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 4: Validation and Qualification | - Validation lifecycle
|
| Topic 5: Quality Control and Laboratory Systems | - Testing and release systems
|
| Topic 6: Production and Process Control | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Evidence of printed material reconciliation is required to:
Response:
- A. Monitor employee performance
- B. Ensure correct material usage and account for discrepancies
- C. Track the number of breaks taken by employees
- D. Justify budget increases
Correct Answer: B 🗳️
Which of the following is NOT typically a component of a change implementation plan?
Response:
- A. Timeline and milestones
- B. Detailed resource allocation
- C. Competitor analysis
- D. Stakeholder communication strategy
Correct Answer: C 🗳️
Contamination controls in filling operations are designed to prevent:
(Select two)
Response:
- A. Physical contamination
- B. Microbial contamination
- C. Operational delays
- D. Financial losses
Correct Answer: A,B 🗳️
Closed computerized systems are defined by their:
Response:
- A. Ability to operate on an open internet platform without security
- B. Inability to process data efficiently
- C. Use exclusively in social networking contexts
- D. Lack of connectivity with other systems and controlled access
Correct Answer: D 🗳️
When reviewing cleaning procedures, it is important to verify that they:
(Choose two)
Response:
- A. Include details on cleaning schedules and methods
- B. Focus on the use of environmentally friendly cleaning agents only
- C. Enhance the equipment's aesthetic features
- D. Are aligned with the latest cleaning validation
Correct Answer: A,D 🗳️
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