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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 2: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 3: Production and Process Control | - Manufacturing operations
|
| Topic 4: Quality Control and Laboratory Systems | - Testing and release systems
|
| Topic 5: GMP Regulations and Compliance | - Regulatory frameworks
|
| Topic 6: Validation and Qualification | - Validation lifecycle
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Which factors should be analyzed post-change?
(Choose two)
Response:
- A. Employee satisfaction
- B. Impact on product quality
- C. New risk factors
- D. Cost-effectiveness
Correct Answer: B,C 🗳️
Which documents are essential for demonstrating staff development and proficiency?
(Choose two)
Response:
- A. Training certificates
- B. Financial statements
- C. Performance appraisals
- D. Vacation records
Correct Answer: A,C 🗳️
The process of ensuring that hand-applied labels are 100% inspected is to:
Response:
- A. Increase packaging time
- B. Create more work for inspectors
- C. Ensure labeling accuracy
- D. Reduce the need for automated systems
Correct Answer: C 🗳️
Mutual recognition agreements impact the import and export of pharmaceuticals by:
Response:
- A. Requiring additional testing for all imported or exported products.
- B. Facilitating smoother regulatory approval processes between countries.
- C. Increasing the number of required inspections for each product.
- D. Ensuring that product prices are consistent across borders.
Correct Answer: B 🗳️
In terms of laboratory record-keeping, electronic systems are preferred because they:
Response:
- A. Can be easily altered without detection
- B. Are more difficult to use than paper systems
- C. Eliminate the need for audit trails
- D. Require less physical space than paper records
Correct Answer: D 🗳️






