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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| 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 |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Quality Systems | 18% | - Quality management system design and implementation - Audits, corrective and preventive actions - Documentation, change control, and records management |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
In the context of pharmacovigilance, the primary focus is on:
Response:
- A. Overseeing the financial management of pharmaceutical products
- B. Assessing and improving patient safety
- C. Monitoring stock levels and production efficiency
- D. Ensuring effective advertising compliance
Correct Answer: B 🗳️
Which of the following is NOT a standard or regulation relevant to the pharmaceutical industry?
Response:
- A. GMP
- B. GSP
- C. GDP
- D. GCP
Correct Answer: B 🗳️
The main difference between retest dates and expiration dates is that:
Response:
- A. Retest dates are used for marketing purposes.
- B. Retest dates require the material to be checked for continued compliance; expiration dates signal the end of a product's usable life.
- C. Expiration dates suggest when to start using a product.
- D. There is no significant difference; both are chosen arbitrarily.
Correct Answer: B 🗳️
The chain of custody for a sample ensures that:
Response:
- A. The sample can be stored indefinitely
- B. The sample is visually appealing
- C. The sample requires minimal storage space
- D. The history of the sample handling is documented and traceable
Correct Answer: D 🗳️
Staff performing inspections should:
Response:
- A. Focus on speed over accuracy
- B. Rely on manual checks on
- C. Have frequent breaks from inspection
- D. Avoid periodic eye examinations
Correct Answer: C 🗳️
