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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Facilities and Equipment Systems | 18%-22% | - Equipment
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Materials Systems | 13%-17% | - Material controls
|
| Production Systems | 23%-27% | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Immediate actions in response to a trigger event should aim to:
Response:
- A. Immediately resolve the underlying issue without investigation
- B. Contain any potential impact
- C. Eliminate the need for further action
- D. Assign blame to responsible parties
Correct Answer: B 🗳️
Which document details post-approval changes in pharmaceutical manufacturing?
Response:
- A. Marketing Authorization
- B. Clinical Trial Report
- C. Product Monograph
- D. SUPAC guidelines
Correct Answer: D 🗳️
The maintenance of the qualified state through utilities change control is important to:
Response:
- A. Prevent any compromise to product quality and compliance
- B. Ensure that utilities are the center of attention during audits
- C. Keep the utilities up to date with the latest fashion trends
- D. Facilitate rapid changes in utility colors and designs
Correct Answer: A 🗳️
Before a piece of equipment is used in production, which types of acceptance testing are typically conducted?
(Choose two)
Response:
- A. Personal Acceptance Testing (PAT)
- B. Online Acceptance Testing (OAT)
- C. Site Acceptance Testing (SAT)
- D. Factory Acceptance Testing (FAT)
Correct Answer: C,D 🗳️
Why are license renewal inspections conducted in the pharmaceutical industry? Response:
- A. To provide opportunities for public relations.
- B. To update the company's product list.
- C. To ensure ongoing compliance with regulatory standards.
- D. To reassess the company's market value.
Correct Answer: C 🗳️
