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Updated: Jul 25, 2026
No. of Questions: 520 Questions & Answers with Testing Engine
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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 |
| Related Certifications: | Certified Medical Device Auditor (CMDA) Certified Quality Auditor (CQA) |
| Exam Price: | $450 (Member) / $550 (Non-Member) / $350 (Retake) |
| Real Exam Qty: | 150 - 165 |
| Certificate Validity Period: | 3 years |
| Exam Format: | Multiple Choice, Open Book, Computer-Based / Paper & Pencil |
| Available Languages: | English |
| Exam Duration: | 240 - 258 |
| Recommended Training: | ASQ CPGP Preparation Courses CPGP Handbook |
| 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 |
|---|---|---|
| Topic 1: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 2: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 3: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 4: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 5: Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Topic 6: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 7: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 8: Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements - Process design, validation, and control |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Phase-appropriate GMPs during the product life cycle ensure:
Response:
A) Consistency in product branding
B) Uniformity in product color
C) Compliance with regulatory requirements
D) Simplification of marketing strategies
2. ICH Q9 focuses on:
A) Stability requirements
B) Clinical trials
C) Risk management
D) Analytical validation
3. Which of the following is an example of a critical quality attribute?
Response:
A) The font used on the product label
B) The color of the tablet coating
C) The product name
D) Sterility for injectable products
4. What should be done with damaged materials upon receipt?
Response:
A) Use them as if they were undamaged
B) Quarantine and assess for further action
C) Ignore the damage and proceed with production
D) Donate them to charity
5. The main elements of a quality agreement typically include:
Response:
A) Guarantees of stock price performance
B) Scope and purpose, roles and responsibilities, and dispute resolution procedures
C) Entertainment allowances for supplier visits
D) Plans for joint marketing initiatives
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: B | Question # 5 Answer: B |
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