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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 2: Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements - Process design, validation, and control |
| Topic 3: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 4: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 5: Quality Systems | 18% | - Audits, corrective and preventive actions - Quality management system design and implementation - Documentation, change control, and records management |
| Topic 6: Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Topic 7: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 8: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Reviewing compendial or non-compendial requirements is critical for ensuring:(Choose two) Response:
A) The laboratory's social media presence is enhanced.
B) Procedures are in place for both qualification and validation.
C) Test methods are aligned with required compendial chapters.
D) Tests are chosen based on the laboratory's location.
2. What is the primary goal of validating automated or computerized systems in a pharmaceutical environment?
Response:
A) To ensure the system can be operated by anyone without training
B) To verify that critical parameters for operation and maintenance are controlled and monitored
C) To ensure the system's user interface is visually appealing
D) To guarantee the system can operate without electricity
3. Which of these events typically triggers a CAPA in a quality management system?
Response:
A) A scheduled audit with no findings
B) A successful product launch
C) An annual review meeting
D) An observed deviation from standard operating procedures
4. The main reason for the traceability of intermediates in pharmaceutical manufacturing is to:
Response:
A) Allow for creative marketing
B) Make the packaging more attractive
C) Ensure safety and efficacy through the supply chain
D) Reduce the need for quality control
5. Different types of audits include:
(Choose two)
Response:
A) Product audit
B) Process audit
C) Systems audit
D) Financial audit
Solutions:
| Question # 1 Answer: B,C | Question # 2 Answer: B | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: A,C |
