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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
| Topic 1: Documentation and Data Integrity | - GMP documentation practices
- 1. Batch records and SOP control
- 2. Data integrity principles (ALCOA+)
|
| Topic 2: GMP Regulations and Compliance | - Regulatory frameworks
- 1. ICH guidelines overview
- 2. FDA cGMP requirements
- Inspection readiness
- 1. Audit preparation and response
- 2. Regulatory inspection process
|
| Topic 3: Validation and Qualification | - Validation lifecycle
- 1. Process and cleaning validation
- 2. Equipment qualification (IQ/OQ/PQ)
|
| Topic 4: Pharmaceutical Quality Systems | - Quality system principles and implementation
- 1. Continuous improvement and quality metrics
- 2. Quality management system structure in pharma GMP environments
|
| Topic 5: Production and Process Control | - Manufacturing operations
- 1. Process validation and control strategies
- 2. In-process controls and monitoring
|
| Topic 6: Quality Control and Laboratory Systems | - Testing and release systems
- 1. Sampling and testing methodologies
- 2. Batch release and specification compliance
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. The effectiveness of a QMS is assessed through QMM to ensure:
Response:
A) Competitive pricing
B) Legal compliance
C) Process and product quality
D) Effective advertising
2. Dispensing materials requires consideration of which factors?
Response:
A) The personal preferences of the manufacturing staff
B) The color coordination with the brand
C) The popularity of the product
D) Proper cleaning, labeling, and environmental controls
3. Which of the following requirements is essential for the manufacture and storage environment in a pharmaceutical facility?
Response:
A) Presence of a cafeteria within the production area
B) Availability of a large parking lot
C) High-tech security systems
D) Appropriate lighting, ventilation, and drainage
4. Environmental monitoring is least likely to be a focus during which phase of product development?
Response:
A) Commercial production
B) Product concept development
C) Pre-clinical trials
D) Phase I clinical trials
5. Record review processes are essential for ensuring:
Response:
A) Uniformity in record formatting
B) Entertainment value of the data
C) Data integrity and preventing data loss
D) Quick disposal of outdated records
Solutions:
Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: B | Question # 5 Answer: C |