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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
| Topic 1: Production and Process Control | - Manufacturing operations
- 1. Process validation and control strategies
- 2. In-process controls and monitoring
|
| Topic 2: Quality Control and Laboratory Systems | - Testing and release systems
- 1. Batch release and specification compliance
- 2. Sampling and testing methodologies
|
| Topic 3: Documentation and Data Integrity | - GMP documentation practices
- 1. Batch records and SOP control
- 2. Data integrity principles (ALCOA+)
|
| Topic 4: Pharmaceutical Quality Systems | - Quality system principles and implementation
- 1. Quality management system structure in pharma GMP environments
- 2. Continuous improvement and quality metrics
|
| Topic 5: 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 6: Validation and Qualification | - Validation lifecycle
- 1. Equipment qualification (IQ/OQ/PQ)
- 2. Process and cleaning validation
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Routine maintenance of air and water filters in a pharmaceutical facility helps to:
Response:
A) Prevent contamination and maintain a controlled environment
B) Ensure the filters are color-coordinated with the facility interiors
C) Decrease the workload on facility staff
D) Impress regulatory inspectors with the facility's cleanliness
2. GMP requirements for clinical trials material focus on:
(Select two)
Response:
A) Simplifying production processes
B) Ensuring patient safety
C) Guaranteeing the efficacy of the product
D) Enhancing the product's marketability
3. Which of the following best describes a product complaint?
Response:
A) A report of dissatisfaction concerning a company's service.
B) A report of a financial loss due to the use of a product.
C) A report of any dissatisfaction with a product's quality, identity, durability, reliability, safety, effectiveness, or performance.
D) A report of a side effect experienced by a patient or consumer using a pharmaceutical product.
4. Staff performing inspections should:
Response:
A) Rely on manual checks on
B) Avoid periodic eye examinations
C) Have frequent breaks from inspection
D) Focus on speed over accuracy
5. PIC/S guidelines emphasize the importance of data integrity. Which of the following is a key aspect of these guidelines?
Response:
A) Documentation practices must prevent data tampering.
B) Records must be stored in a public cloud for accessibility.
C) Data should be reproducible under similar conditions.
D) Data should be easily editable by anyone.
Solutions:
Question # 1 Answer: A | Question # 2 Answer: B,C | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: A |