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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 2: GMP Regulations and Compliance | - Inspection readiness
|
| Topic 3: Validation and Qualification | - Validation lifecycle
|
| 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:
Question 1
Handling utensils for dispensing materials should be:
Response:
A. Color-coordinated with the product
B. The most expensive to ensure quality
C. Chosen by the manufacturing staff based on personal preference
D. Selected and managed according to the type of material and manufacturing process
Question 2
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D. Quick disposal of outdated records
Question 3
Before a piece of equipment is used in production, which types of acceptance testing are typically conducted?
(Choose two)
Response:
A. Site Acceptance Testing (SAT)
B. Online Acceptance Testing (OAT)
C. Personal Acceptance Testing (PAT)
D. Factory Acceptance Testing (FAT)
Question 4
In-process control studies during technology transfer ensure:
Response:
A. Consistent product branding
B. Effective marketing campaigns
C. Continual process control
D. Employee satisfaction
Question 5
Which of the following is NOT a part of the complaint handling process?
Response:
A. Determining the necessary corrective actions.
B. Documenting the complaint in detail.
C. Investigating the cause of the complaint.
D. Ignoring complaints that are not submitted in writing.
Solutions:
| Question 1 Answer: D | Question 2 Answer: C | Question 3 Answer: A,D | Question 4 Answer: C | Question 5 Answer: D |



