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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. When assessing the impact of proposed changes, what should be considered?
Response:

A) Only direct costs
B) The time taken for implementation
C) The opinions of senior management only
D) Impact on all relevant aspects including products, processes, and systems

2. Which document captures equipment cleaning traceability?

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

3. A comprehensive approach to managing laboratory instruments includes classification, qualification, calibration, and _______.
Response:

A) disposal
B) preventive maintenance
C) random checks
D) neglect

4. What are essential elements to review in Certificates of Analysis (COAs)?
(Choose two)
Response:

A) Completeness and internal review
B) Appropriate retention and accessibility
C) Marketing claims
D) Color of the product

5. Which principle is central to data integrity?

A) Restricted access
B) Editable data
C) Fast reporting
D) ALCOA

Solutions: