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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Documentation and Data Integrity | - GMP documentation practices
|
| Quality Control and Laboratory Systems | - Testing and release systems
|
| Production and Process Control | - Manufacturing operations
|
| GMP Regulations and Compliance | - Inspection readiness
|
| Validation and Qualification | - Validation lifecycle
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Which of the following is a key aspect of the disposition process for reprocessed and reworked materials?Response:
- A. Avoiding any quality checks
- B. Storing them together with active pharmaceutical ingredients
- C. Applying appropriate documentation and approval methods
- D. Mixing them with new batches without approval
Correct Answer: C 🗳️
When should specifications be reviewed and updated?
Response:
- A. Only when the product formula changes
- B. Annually, as a standard procedure
- C. When methods are revised or compendia are changed
- D. When a new management team is appointed
Correct Answer: C 🗳️
The maintenance of the qualified state through utilities change control is important to:
Response:
- A. Prevent any compromise to product quality and compliance
- B. Keep the utilities up to date with the latest fashion trends
- C. Facilitate rapid changes in utility colors and designs
- D. Ensure that utilities are the center of attention during audits
Correct Answer: A 🗳️
Line clearance is performed to:
- A. Verify environmental conditions
- B. Prevent mix-ups before production
- C. Verify batch yield
- D. Support release decisions
Correct Answer: B 🗳️
Vision and detection systems must be:
(Select two)
Response:
- A. Available in multiple colors
- B. Challenged regularly
- C. Qualified
- D. Calibrated
Correct Answer: C,D 🗳️
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