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Updated: Aug 13, 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 |
| Exam Duration: | 240 - 258 |
| Real Exam Qty: | 150 - 165 |
| Exam Format: | Multiple Choice, Open Book, Computer-Based / Paper & Pencil |
| Exam Price: | $450 (Member) / $550 (Non-Member) / $350 (Retake) |
| Passing Score: | 550 / 750 |
| Certificate Validity Period: | 3 years |
| Available Languages: | English |
| Related Certifications: | Certified Medical Device Auditor (CMDA) Certified Quality Auditor (CQA) |
| 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 |
|---|---|---|
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements - Process design, validation, and control |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. In the context of APR and PQR, what is the significance of reviewing product complaints?
Response:
A) To adjust the product price
B) To evaluate and improve product quality and safety
C) To measure consumer brand loyalty
D) To assess the product's packaging design
2. Revalidation of processes is NOT typically required when:Response:
A) There are significant changes to the process
B) New equipment is introduced
C) Regulatory guidelines change
D) The product design is slightly altered for marketing purposes
3. The primary objective of a Quality Management System (QMS) is to ensure:
Response:
A) Marketing effectiveness
B) Product quality
C) Investor satisfaction
D) Product affordability
4. Application of ICH Q9 helps in:
Response:
A) Determining the company's stock value
B) Designing product packaging
C) Selecting marketing strategies
D) Identifying and controlling risks to product quality
5. What information must be included on the identification label of stored materials?
Response:
A) Required information such as material name, lot number, and expiry/retest date
B) The favorite color of the warehouse manager
C) Aesthetic descriptions of the material
D) The name of the employee who stored the material
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: A |
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Frequently Asked Questions
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