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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Validation and Qualification | - Validation lifecycle
|
| Topic 2: GMP Regulations and Compliance | - Inspection readiness
|
| Topic 3: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 4: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 5: Quality Control and Laboratory Systems | - Testing and release systems
|
| Topic 6: Production and Process Control | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Reserve samples must be retained to:
Response:
A) Comply with regulatory requirements for post-market testing
B) Enable future promotional activities
C) Enhance the laboratory's collection
D) Reduce manufacturing costs
2. Revalidation of processes is NOT typically required when:Response:
A) New equipment is introduced
B) Regulatory guidelines change
C) The product design is slightly altered for marketing purposes
D) There are significant changes to the process
3. In managing outsourced processes, it is critical to:
Response:
A) Allow the contractor to operate independently without oversight
B) Limit the communication with the contractor to reduce interference
C) Focus solely on the cost-effectiveness of the outsourcing arrangement
D) Define the roles and responsibilities of each party
4. Label printing accuracy during packaging is verified by:
Response:
A) Customer feedback
B) Sales data comparison
C) Documenting and confirming correctness
D) Competitive analysis
5. Contamination controls in filling operations are designed to prevent:
(Select two)
Response:
A) Operational delays
B) Microbial contamination
C) Physical contamination
D) Financial losses
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: B,C |
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