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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Materials Systems | 13%-17% | - Material controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Facilities and Equipment Systems | 18%-22% | - Equipment
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The _____ acts as a liaison between regulatory authorities and the pharmaceutical company.
Response:
- A. Chief Financial Officer
- B. Management Representative
- C. Marketing Director
- D. CEO
Correct Answer: B 🗳️
Technology transfer is crucial when there is a __________ change.
Response:
- A. sales team
- B. manufacturing site
- C. marketing strategy
- D. packaging color
Correct Answer: B 🗳️
ICH Q7 provides guidance specifically for:
Response:
- A. Good Distribution Practice
- B. Good Clinical Practice
- C. Good Laboratory Practice
- D. Good Manufacturing Practice
Correct Answer: D 🗳️
When labeling reagents, solutions, and standards, which of the following information must be included?
Response:
- A. Opened-on date, expiry date, and quantity
- B. Physical appearance and smell
- C. Color and viscosity
- D. Price and supplier name
Correct Answer: A 🗳️
What is the primary purpose of monitoring supplier quality management systems?
Response:
- A. To increase supplier dependency
- B. To reduce the cost of procurement
- C. To ensure suppliers comply with legal requirements
- D. To negotiate better contract terms
Correct Answer: C 🗳️
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