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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Product Development and Technology Transfer9%- Product lifecycle management and regulatory submissions
- Technology transfer, scale-up, and validation
Manufacturing Systems16%- Sterile and non-sterile production requirements
- Process design, validation, and control
- Contamination control, cleaning, and hygiene
Laboratory Systems14%- Testing methods, data integrity, and result reporting
- Laboratory controls, calibration, and validation
Filling, Packaging, and Labeling13%- Packaging and labeling design and compliance
- Filling operations, controls, and verification
Infrastructure and Facilities12%- Equipment qualification, calibration, and cleaning validation
- Facility design, maintenance, and utilities management
Materials and Supply Chain Management12%- Inventory control, traceability, and distribution practices
- Supplier qualification, material receipt, and storage
Quality Systems18%- Audits, corrective and preventive actions
- Documentation, change control, and records management
- Quality management system design and implementation
Regulatory Agency Governance12%- Global regulatory framework and requirements
- Inspection, enforcement, and compliance processes

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Which document captures equipment cleaning traceability?

A) SOP
B) Batch record
C) Cleaning log
D) Material release checklist


2. Reserve samples must be retained to:
Response:

A) Reduce manufacturing costs
B) Comply with regulatory requirements for post-market testing
C) Enhance the laboratory's collection
D) Enable future promotional activities


3. The Japanese Pharmacopoeia (JP) is primarily required for marketing authorization in:
Response:

A) Europe
B) All countries worldwide
C) Japan
D) The United States


4. Formal contracts or quality agreements with suppliers should include provisions for:
(Choose two)
Response:

A) Continuous improvement and corrective action procedures
B) Audit and inspection rights
C) Regular social events to maintain a good working relationship
D) Flexible payment terms based on the buyer's financial condition


5. Which of the following are critical components of a metrology program?
(Choose two)
Response:

A) Calibration of instruments
B) Social media presence
C) Engineering change control
D) Celebrity endorsements


Solutions:

Question # 1
Answer: C
Question # 2
Answer: B
Question # 3
Answer: C
Question # 4
Answer: A,B
Question # 5
Answer: A,C

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