CPGP Complete Exam Dumps & CPGP Cert
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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q79-Q84):
NEW QUESTION # 79
A major change in a validated process requires:
- A. Approval but no documentation
- B. Engineering notification only
- C. Change control and potential re-validation
- D. No action if risk is low
Answer: C
NEW QUESTION # 80
In relation to combination products, the studies required to meet GMP requirements often include:
Response:
- A. Drug-device interaction studies
- B. Financial impact assessments
- C. Long-term storage tests under various conditions
- D. Consumer preference surveys
Answer: A
NEW QUESTION # 81
According to regulatory requirements, which characteristic is NOT part of the ALCOA principle for ensuring the integrity of records?
Response:
- A. Accurate.
- B. Optional.
- C. Original.
- D. Legible.
Answer: C
NEW QUESTION # 82
The necessity of equipment cleaning validation varies depending on:
Response:
- A. The personal preferences of the cleaning staff
- B. Whether the equipment is single-use, multi-use, or dedicated
- C. The color and size of the equipment
- D. The season in which the cleaning occurs
Answer: B
NEW QUESTION # 83
Preventive actions are implemented to:
Response:
- A. Ensure compliance with budget constraints
- B. Address non-conformities that have already occurred
- C. Recognize employee achievements
- D. Prevent potential future non-conformities
Answer: D
NEW QUESTION # 84
......
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