Exam Name: Certified Pharmaceutical GMP Professional
Certification Provider: ASQ
Corresponding Certification: ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Laboratory Systems | 10%-14% | - Laboratory operations
|
| Topic 2: Materials Systems | 13%-17% | - Material controls
|
| Topic 3: Facilities and Equipment Systems | 18%-22% | - Equipment
|
| Topic 4: Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Topic 5: Quality Management Systems | 22%-26% | - Quality systems
|
| Topic 6: Production Systems | 23%-27% | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Audit evidence should be _____ to confirm audit completion and findings.
Response:
- A. ignored
- B. estimated
- C. deleted
- D. documented
Correct Answer: D 🗳️
Label printing during packaging requires:
Response:
- A. Minimal attention to detail
- B. Periodic breaks for operators
- C. Documentation and verification of correctness
- D. Use of the cheapest available ink
Correct Answer: C 🗳️
The maintenance of the qualified state through utilities change control is important to:
Response:
- A. Ensure that utilities are the center of attention during audits
- B. Prevent any compromise to product quality and compliance
- C. Facilitate rapid changes in utility colors and designs
- D. Keep the utilities up to date with the latest fashion trends
Correct Answer: B 🗳️
For how long should GMP-related records be retained, according to most regulatory guidelines?
Response:
- A. Only during the period of product manufacturing.
- B. Until the product expiration date plus one year.
- C. For the lifetime of the company for historical reference.
- D. For a minimum of 5 years after the product's commercial release.
Correct Answer: D 🗳️
Product audits evaluate the final _____ to ensure it meets all specifications and requirements.
Response:
- A. process
- B. product
- C. idea
- D. proposal
Correct Answer: B 🗳️
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