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ASQ CPGP Exam Overview:
| Certification Vendor: | ASQ |
|---|---|
| Exam Name: | Certified Pharmaceutical GMP Professional (CPGP) Certification Exam |
| Exam Number: | CPGP |
| Real Exam Qty: | 165 |
| Available Languages: | English |
| Exam Format: | Multiple-choice |
| Exam Duration: | 300 minutes |
| Exam Price: | Varies by membership status (typically USD; check official ASQ pricing page) |
| Certificate Validity Period: | 3 years (recertification required) |
| Passing Score: | 550/750 (scaled score) |
| Related Certifications: | ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) ASQ Certified Quality Auditor (CQA) ASQ Certified Quality Engineer (CQE) |
| Recommended Training: | ASQ CPGP Preparation Resources |
| Exam Registration: | ASQ Certification Registration |
| Sample Questions: | ASQ CPGP Sample Questions |
| Exam Way: | Computer-based exam (proctored, delivered at testing centers or online depending on region availability) |
| Pre Condition: | Recommended: 3 years of experience in pharmaceutical GMP environment or related quality/regulatory role |
| Official Syllabus URL: | https://asq.org/cert/pharmaceutical-gmp-professional |
ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: GMP Regulations and Compliance | - Regulatory frameworks
|
| Topic 2: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 3: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 4: Validation and Qualification | - Validation lifecycle
|
| Topic 5: Production and Process Control | - Manufacturing operations
|
| Topic 6: Quality Control and Laboratory Systems | - Testing and release systems
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question #1
Biological product deviation reports are crucial for:
Response:
- A. Tracking deviations in biological product manufacturing or handling
- B. Reporting changes in executive leadership
- C. Cataloging cafeteria incidents
- D. Logging daily employee attendance
Correct Answer: A 🗳️
Question #2
Equipment planning in the pharmaceutical industry requires consideration of:
Response:
- A. The equipment's compatibility with the interior design of the facility
- B. Location, design, and maintenance requirements based on operational needs
- C. The brand and model of the equipment for status symbols
- D. The potential for the equipment to be used as a fitness device by employees
Correct Answer: B 🗳️
Question #3
How should a pharmaceutical company prepare for a remote evaluation?
Response:
- A. By training staff on remote communication tools and digital documentation practices.
- B. By increasing the security around their physical facilities.
- C. By organizing a public relations campaign.
- D. By revising their product pricing strategy.
Correct Answer: A 🗳️
Question #4
Cleaning and maintenance schedules for equipment are crucial to:
Response:
- A. Ensure they are always shiny and attractive
- B. Keep the equipment smelling nice
- C. Ensure they meet regulatory requirements for cleanliness and function
- D. Impress visitors and auditors with the appearance of the equipment
Correct Answer: C 🗳️
Question #5
Traceability for incoming materials ensures that each component can be tracked back to its
___________.
Response:
- A. Color scheme
- B. Original source
- C. Social media profile
- D. Marketing campaign
Correct Answer: B 🗳️
By Joyce
