- Exam Code: CPGP
- Exam Name: Certified Pharmaceutical GMP Professional
- Certification Provider: ASQ
- Corresponding Certification:ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Quality Systems | 18% | - Quality management system design and implementation - Documentation, change control, and records management - Audits, corrective and preventive actions |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| 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. Why is it important to differentiate requirements for the sampling environment based on the type of material?
Response:
A) Different materials require different ambient conditions to prevent alteration or contamination
B) It allows staff to choose their preferred working environment
C) To accommodate the personal preferences of the material suppliers
D) It is solely for regulatory compliance, without practical benefits
2. The primary purpose of supplier audits is to:
A) Reduce cost
B) Monitor supplier compliance and quality
C) Evaluate marketing capability
D) Check financial status
3. Which is the most appropriate disposal method for rejected raw materials?
A) Use for training
B) Give to another manufacturer
C) Return to vendor or destroy
D) Store indefinitely
4. Specification limits are assessed in relation to:
Response:
A) The color of the final product
B) The CEO's preferences
C) The number of employees in the facility
D) Registration or compendial requirements
5. The purpose of a Site Reference File (SRF) includes:
Response:
A) Describing the specifics of a site to inform regulatory inspections
B) Listing the cafeteria menu options
C) Advertising the site for potential investors
D) Presenting the site's annual holiday schedule
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: C | Question # 4 Answer: D | Question # 5 Answer: A |
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