Exam Name: Certified Pharmaceutical GMP Professional
Certification Provider: ASQ
Corresponding Certification: ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 2: Validation and Qualification | - Validation lifecycle
|
| Topic 3: GMP Regulations and Compliance | - Inspection readiness
|
| Topic 4: Quality Control and Laboratory Systems | - Testing and release systems
|
| Topic 5: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 6: Production and Process Control | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Development criteria for in-process inspections should include:
Response:
- A. Color preference surveys
- B. Marketing feedback loops
- C. Packaging aesthetics
- D. Seal tests
When dealing with returned pharmaceutical goods, their ___________ must be carefully evaluated to determine if they can be reissued, recycled, or must be destroyed.
Response:
- A. Disposition
- B. Advertising budget
- C. Price tag
- D. Packaging color
Packaging controls differ based on the:
Response:
- A. Employee preferences
- B. Marketing campaign
- C. Time of year
- D. Type of packaging process
When managing outsourced processes, it's vital to:
(Choose two)
Response:
- A. Focus solely on reducing costs regardless of the impact on product quality
- B. Limit documentation to reduce bureaucracy
- C. Maintain clear and open channels of communication for addressing issues
- D. Ensure that outsourced activities do not impact the overall quality of the product
In the evaluation of atypical results, if initial investigations confirm the atypicality, the next step is to conduct a _______.
Response:
- A. staff reassignment
- B. celebratory meeting
- C. root cause analysis
- D. cost analysis
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