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Updated: Sep 14, 2026
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ASQ CPGP Exam Overview:
| Certification Vendor: | ASQ (American Society for Quality) |
|---|---|
| Exam Name: | Certified Pharmaceutical GMP Professional Exam |
| Exam Number: | CPGP |
| Passing Score: | 550 / 750 |
| Available Languages: | English |
| Exam Duration: | 240 - 258 |
| Certificate Validity Period: | 3 years |
| Exam Format: | Multiple Choice, Open Book, Computer-Based / Paper & Pencil |
| Real Exam Qty: | 150 - 165 |
| Related Certifications: | Certified Quality Auditor (CQA) Certified Medical Device Auditor (CMDA) |
| Exam Price: | $450 (Member) / $550 (Non-Member) / $350 (Retake) |
| Recommended Training: | ASQ CPGP Preparation Courses CPGP Handbook |
| Exam Registration: | ASQ Official Registration Prometric Test Center Scheduling |
| Sample Questions: | ASQ CPGP Sample Questions |
| Exam Way: | Computer-based (online remote proctored or test center) or paper-and-pencil; open-book |
| Pre Condition: | 5 years of full-time experience in GMP-related work; or 4 years with bachelor's degree; or 8 years with high school education; experience must be in decision-making roles |
| Official Syllabus URL: | https://www.asq.org/cert/pharmaceutical-gmp |
ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
A critical aspect of disaster recovery planning for automated systems includes:
Response:
- A. Planning for an unlimited budget to address any disaster
- B. The ability to recover records and maintain data integrity
- C. Ensuring the plan is reviewed and updated only after a disaster occurs
- D. Prioritizing the recovery of the company's gaming systems
Correct Answer: B 🗳️
Which of the following are critical components of a metrology program?
(Choose two)
Response:
- A. Calibration of instruments
- B. Social media presence
- C. Celebrity endorsements
- D. Engineering change control
Correct Answer: A,D 🗳️
Which factor is least relevant when determining the requirements for a sampling environment?
Response:
- A. The adequacy of the lighting and ventilation
- B. The type of material being sampled
- C. The potential for contamination
- D. The latest interior design trends
Correct Answer: D 🗳️
In relation to combination products, the studies required to meet GMP requirements often include:
Response:
- A. Long-term storage tests under various conditions
- B. Financial impact assessments
- C. Consumer preference surveys
- D. Drug-device interaction studies
Correct Answer: D 🗳️
The Quality Management Maturity assessment is used to:
Response:
- A. Evaluate employee satisfaction
- B. Validate financial investment decisions
- C. Check the effectiveness of marketing campaigns
- D. Ensure the QMS evolves with the product and processes
Correct Answer: D 🗳️
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