Exam Name: Certified Pharmaceutical GMP Professional
Certification Provider: ASQ
Corresponding Certification: ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Documentation and Data Integrity | - GMP documentation practices
|
| Validation and Qualification | - Validation lifecycle
|
| GMP Regulations and Compliance | - Inspection readiness
|
| Production and Process Control | - Manufacturing operations
|
| Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Quality Control and Laboratory Systems | - Testing and release systems
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The process of comparing test data with specifications primarily helps to identify:
Response:
- A. Products ready for marketing
- B. Potential areas for cost-cutting
- C. The need for new laboratory equipment
- D. Materials and products that do not meet established quality standards
Correct Answer: D 🗳️
The evaluation of supplier quality systems is important to:
Response:
- A. Identify suppliers capable of meeting or exceeding quality expectations
- B. Simplify the legal aspects of supplier relationships
- C. Facilitate quicker delivery times regardless of quality
- D. Ensure that suppliers are following the latest fashion trends
Correct Answer: A 🗳️
Reviewing test methods against compendial requirements is important to ensure:
Response:
- A. Methods are chosen based on their complexity.
- B. Compliance with both general and informational compendial chapters as needed.
- C. Only non-compendial methods are used in the lab.
- D. The quickest method is chosen for all tests.
Correct Answer: B 🗳️
Staff performing inspections should:
Response:
- A. Avoid periodic eye examinations
- B. Have frequent breaks from inspection
- C. Rely on manual checks on
- D. Focus on speed over accuracy
Correct Answer: B 🗳️
Which of these events typically triggers a CAPA in a quality management system?
Response:
- A. An annual review meeting
- B. A successful product launch
- C. An observed deviation from standard operating procedures
- D. A scheduled audit with no findings
Correct Answer: C 🗳️
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