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Updated: Aug 28, 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 |
| Available Languages: | English |
| Passing Score: | 550 / 750 |
| Certificate Validity Period: | 3 years |
| Exam Format: | Computer-Based / Paper & Pencil, Multiple Choice, Open Book |
| Exam Price: | $450 (Member) / $550 (Non-Member) / $350 (Retake) |
| Exam Duration: | 240 - 258 |
| Related Certifications: | Certified Quality Auditor (CQA) Certified Medical Device Auditor (CMDA) |
| Real Exam Qty: | 150 - 165 |
| Recommended Training: | CPGP Handbook ASQ CPGP Preparation Courses |
| Exam Registration: | Prometric Test Center Scheduling ASQ Official Registration |
| 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 |
|---|---|---|
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Quality Systems | 18% | - Documentation, change control, and records management - Quality management system design and implementation - Audits, corrective and preventive actions |
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
The appropriate storage of samples and reagents is essential to:
Response:
A. Maintain the material's characteristics for accurate testing
B. Enhance the appearance of the laboratory
C. Minimize the space used in the laboratory
D. Make it easier to dispose of after use
Question 2
Needs analysis in training and personnel qualification is essential for determining:
Response:
A. Training content and required qualifications
B. Vacation policies
C. Retirement benefits
D. Bonus structures
Question 3
The main difference between retest dates and expiration dates is that:
Response:
A. Retest dates require the material to be checked for continued compliance; expiration dates signal the end of a product's usable life.
B. Retest dates are used for marketing purposes.
C. There is no significant difference; both are chosen arbitrarily.
D. Expiration dates suggest when to start using a product.
Question 4
Evidence of line clearance must be __________.
Response:
A. verbally communicated
B. ignored
C. documented
D. estimated
Question 5
When reviewing cleaning procedures, it is important to verify that they:
(Choose two)
Response:
A. Are aligned with the latest cleaning validation
B. Focus on the use of environmentally friendly cleaning agents only
C. Include details on cleaning schedules and methods
D. Enhance the equipment's aesthetic features
Solutions:
| Question 1 Answer: A | Question 2 Answer: A | Question 3 Answer: A | Question 4 Answer: C | Question 5 Answer: A,C |
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