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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Topic 2: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 3: Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene - Process design, validation, and control |
| Topic 4: Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Topic 5: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 6: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 7: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 8: 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. Label printing accuracy during packaging is verified by:
Response:
A) Documenting and confirming correctness
B) Sales data comparison
C) Competitive analysis
D) Customer feedback
2. The main elements of a quality agreement typically include:
Response:
A) Entertainment allowances for supplier visits
B) Guarantees of stock price performance
C) Scope and purpose, roles and responsibilities, and dispute resolution procedures
D) Plans for joint marketing initiatives
3. The FDA's regulations are crucial for pharmaceuticals in the USA. What does FDA stand for?
Response:
A) Food and Dietary Association
B) Food and Drug Administration
C) Federal Drug Agency
D) Federal Department of Agriculture
4. Atypical results in microbiological testing often require which of the following actions?
Response:
A) Ignoring the results if they are slightly out of specification
B) Immediate re-testing of the sample
C) Consultation with a third-party laboratory for confirmation
D) Assessment of environmental monitoring data
5. Critical Quality Attributes (CQAs) are:
Response:
A) Unrelated to product safety and efficacy
B) Only related to product packaging
C) Arbitrary product characteristics
D) Characteristics that must be controlled within predefined limits
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: D |
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