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Stability reports are crucial for new product development because they:
Response:
A. Outline marketing strategies
B. Detail the manufacturing costs
C. Demonstrate the product's ability to maintain its quality over time
D. Provide competitor analysis
Answer: C
NEW QUESTION # 468
When reviewing compendial or non-compendial requirements, it is crucial to:
Response:
A. Focus solely on the ease of the test.
B. Ignore the compendial chapters if non-compendial methods are used.
C. Use only the newest methods available, regardless of their compendial status.
D. Ensure test methods are qualified, validated, and verified.
Answer: D
NEW QUESTION # 469
A major change in a validated process requires:
A. Engineering notification only
B. Approval but no documentation
C. Change control and potential re-validation
D. No action if risk is low
Answer: C
NEW QUESTION # 470
What is the primary purpose of having approved specifications for raw materials and finished products?
Response:
A. To reduce the cost of production
B. To simplify the packaging process
C. To increase the speed of production
D. To ensure they meet designated quality and safety standards
Answer: D
NEW QUESTION # 471
Documentation of staff proficiency is important for:
Response:
A. Setting product prices
B. Meeting regulatory requirements
C. Planning office parties
D. Designing advertisements
Answer: B
NEW QUESTION # 472
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