- Exam Code: CPGP
- 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: Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Topic 2: Facilities and Equipment Systems | 18%-22% | - Equipment
|
| Topic 3: Materials Systems | 13%-17% | - Material controls
|
| Topic 4: Laboratory Systems | 10%-14% | - Laboratory operations
|
| Topic 5: Quality Management Systems | 22%-26% | - Quality systems
|
| Topic 6: Production Systems | 23%-27% | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
Which equipment qualification step verifies installation?
A. IQ
B. PQ
C. Validation review
D. OQ
Question 2
The process of _______ review involves evaluating test methods, qualifications, validation, and verification against required compendial chapters.
Response:
A. compendial or non-compendial requirements
B. administrative
C. personnel performance
D. financial
Question 3
What is the main purpose of assessing post-marketing changes in pharmaceuticals?
Response:
A. To adjust the product's market price
B. To evaluate their impact on safety and efficacy
C. To update marketing strategies
D. To redesign the product packaging
Question 4
How do retest dates differ from expiration dates on pharmaceutical materials?
Response:
A. Retest dates are only used for decorative purposes.
B. Retest dates indicate when a material should be re-evaluated for quality; expiration dates indicate when a material is no longer safe to use.
C. Expiration dates are suggestions, while retest dates are mandatory.
D. Retest dates and expiration dates are interchangeable terms.
Question 5
To ensure successful technology transfer, it's important to consider:
(Select two)
Response:
A. Social media marketing strategies
B. Shipping conditions
C. Branding guidelines
D. Hold times
Solutions:
| Question 1 Answer: A | Question 2 Answer: A | Question 3 Answer: B | Question 4 Answer: B | Question 5 Answer: C,D |
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