Updated: Oct 13, 2026
No. of Questions: 520 Questions & Answers with Testing Engine
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| Certification Vendor: | ASQ (American Society for Quality) |
|---|---|
| Exam Name: | Certified Pharmaceutical GMP Professional Exam |
| Exam Number: | CPGP |
| Exam Format: | Open Book, Computer-Based / Paper & Pencil, Multiple Choice |
| Available Languages: | English |
| Real Exam Qty: | 150 - 165 |
| Related Certifications: | Certified Quality Auditor (CQA) Certified Medical Device Auditor (CMDA) |
| Exam Duration: | 240 - 258 |
| Certificate Validity Period: | 3 years |
| Passing Score: | 550 / 750 |
| Exam Price: | $450 (Member) / $550 (Non-Member) / $350 (Retake) |
| Recommended Training: | CPGP Handbook ASQ CPGP Preparation Courses |
| 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 |
| Section | Weight | Objectives |
|---|---|---|
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| 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 |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Quality Systems | 18% | - Quality management system design and implementation - Audits, corrective and preventive actions - Documentation, change control, and records management |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
Process capability studies are conducted to:
Response:
Correct Answer: D 🗳️
Which is NOT a technique used for environmental monitoring?
Response:
Correct Answer: C 🗳️
Management responsibility in the CAPA process includes:
(Choose two)
Response:
Correct Answer: A,C 🗳️
Successful technology transfer activities include all EXCEPT:
Response:
Correct Answer: B 🗳️
Process capability indices (Cp and Cpk) are used to:
Response:
Correct Answer: C 🗳️
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