Exam Name: Certified Pharmaceutical GMP Professional
Certification Provider: ASQ
Corresponding Certification: ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Validation and Qualification | - Validation lifecycle
|
| Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Quality Control and Laboratory Systems | - Testing and release systems
|
| GMP Regulations and Compliance | - Inspection readiness
|
| Documentation and Data Integrity | - GMP documentation practices
|
| Production and Process Control | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Which of the following are valid environmental monitoring tools?
(Select two)
Response:
- A. Financial performance tracking software
- B. Nonviable particulate measuring instruments
- C. Viable particulate measuring instruments
- D. Employee satisfaction surveys
Correct Answer: B,C 🗳️
Which ICH guideline focuses on Quality Risk Management?
Response:
- A. ICH Q9
- B. ICH Q11
- C. ICH Q10
- D. ICH Q12
Correct Answer: A 🗳️
Utilities change control is vital for:
Response:
- A. Keeping up with interior design trends
- B. Maintaining the qualified state of affected utilities
- C. Making utilities more user-friendly for new employees
- D. Ensuring utilities are visible in promotional materials
Correct Answer: B 🗳️
The impact analysis for a proposed change should NOT:
Response:
- A. Ignore potential impacts on regulatory compliance
- B. Consider only the positive outcomes
- C. Be limited to immediate effects
- D. Exclude input from external consultants
Correct Answer: B 🗳️
When assessing the impact of proposed changes, what should be considered?
Response:
- A. Only direct costs
- B. The time taken for implementation
- C. Impact on all relevant aspects including products, processes, and systems
- D. The opinions of senior management only
Correct Answer: C 🗳️
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