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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Materials Systems | 13%-17% | - Material controls
|
| Topic 2: Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Topic 3: Quality Management Systems | 22%-26% | - Quality systems
|
| Topic 4: Laboratory Systems | 10%-14% | - Laboratory operations
|
| Topic 5: Production Systems | 23%-27% | - Manufacturing operations
|
| Topic 6: Facilities and Equipment Systems | 18%-22% | - Equipment
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Which of the following are considered global regulatory reporting requirements?
(Choose three)
Response:
A) Supplements
B) Product recalls
C) Marketing approvals
D) Field alerts
2. In the context of APR and PQR, what is the significance of reviewing product complaints?
Response:
A) To evaluate and improve product quality and safety
B) To measure consumer brand loyalty
C) To adjust the product price
D) To assess the product's packaging design
3. When assessing the impact of proposed changes, what should be considered?
Response:
A) Impact on all relevant aspects including products, processes, and systems
B) The time taken for implementation
C) Only direct costs
D) The opinions of senior management only
4. When labeling reagents, solutions, and standards, which of the following information must be included?
Response:
A) Price and supplier name
B) Color and viscosity
C) Opened-on date, expiry date, and quantity
D) Physical appearance and smell
5. Handling utensils for dispensing materials should be:
Response:
A) Chosen by the manufacturing staff based on personal preference
B) Selected and managed according to the type of material and manufacturing process
C) Color-coordinated with the product
D) The most expensive to ensure quality
Solutions:
| Question # 1 Answer: A,B,D | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: B |
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