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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Quality Management Systems | 22%-26% | - Quality systems
|
| Topic 2: Materials Systems | 13%-17% | - Material controls
|
| Topic 3: Facilities and Equipment Systems | 18%-22% | - Facilities
|
| Topic 4: Production Systems | 23%-27% | - Manufacturing operations
|
| Topic 5: Laboratory Systems | 10%-14% | - Laboratory operations
|
| Topic 6: Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Reprocessing differs from reworking in that reprocessing:Response:
A) Does not require documentation
B) Is always prohibited
C) Involves adjusting materials to meet specifications without changing the batch
D) Requires changing the original manufacturing process
2. Which equipment qualification step verifies installation?
A) Validation review
B) PQ
C) OQ
D) IQ
3. The main goal of evaluating the level of action needed in response to adverse events is to:
Response:
A) Protect patient safety and comply with regulatory requirements.
B) Determine the financial impact on the company.
C) Minimize legal liability for the company.
D) Ensure customer satisfaction and retention.
4. The investigation of atypical results in biological testing involves reviewing _______ to identify potential sources of error.
Response:
A) test protocols, environmental controls, equipment logs
B) financial reports
C) personnel vacation schedules
D) marketing strategies
5. Formal contracts or quality agreements with suppliers should include provisions for:
(Choose two)
Response:
A) Audit and inspection rights
B) Flexible payment terms based on the buyer's financial condition
C) Regular social events to maintain a good working relationship
D) Continuous improvement and corrective action procedures
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: A,D |



