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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| 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 |
| 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 |
| Quality Systems | 18% | - Documentation, change control, and records management - Quality management system design and implementation - Audits, corrective and preventive actions |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. What is a key method to minimize the risk of material mix-ups?
Response:
A) Using the same storage containers for all materials
B) Implementing lot-control methods and proper labeling
C) Storing all materials together to save space
D) Assigning storage based on the material's color
2. Filling equipment control is essential for:
Response:
A) Reducing the need for operator training
B) Simplifying maintenance schedules
C) Verifying filling criteria are met
D) Ensuring the equipment looks modern
3. Revalidation of processes is NOT typically required when:Response:
A) Regulatory guidelines change
B) The product design is slightly altered for marketing purposes
C) There are significant changes to the process
D) New equipment is introduced
4. Environmental conditions during production are monitored using:
Response:
A) Settling plates and active air sampling
B) Customer satisfaction surveys
C) Product sales data
D) Social media analytics
5. When an adverse event report involves a counterfeit product, the company should:
Response:
A) Ignore the report, as it does not involve a genuine product.
B) Inform regulatory authorities and possibly issue a public warning to prevent further harm.
C) Only inform the direct customers about the counterfeit product.
D) Consider the event as a minor issue that does not require action.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: A | Question # 5 Answer: B |
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