- 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 |
|---|---|---|
| Topic 1: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 2: Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Topic 3: Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Topic 4: Quality Systems | 18% | - Quality management system design and implementation - Documentation, change control, and records management - Audits, corrective and preventive actions |
| Topic 5: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 6: Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| Topic 7: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 8: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Quality agreements are essential because they:
Response:
- A. Serve as a formal record of the partnership for marketing purposes
- B. Allow for the informal resolution of disputes
- C. Provide a platform for socializing with suppliers
- D. Clearly define product and service quality requirements and responsibilities
Trend analysis in the context of CAPA is crucial for:
Response:
- A. Designing new product lines
- B. Planning social media campaigns
- C. Predicting stock market trends
- D. Identifying recurring or new issues
Evidence of printed material reconciliation is required to:
Response:
- A. Justify budget increases
- B. Track the number of breaks taken by employees
- C. Ensure correct material usage and account for discrepancies
- D. Monitor employee performance
A major change in a validated process requires:
- A. Approval but no documentation
- B. Engineering notification only
- C. No action if risk is low
- D. Change control and potential re-validation
During laboratory investigations, _______ methods are reviewed to ensure they are verified as suitable for use in the testing lab.
Response:
- A. unverified
- B. outdated
- C. improvised
- D. compendial
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