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1. Which qualifications ensure that facilities, equipment, and utilities perform correctly under their operational range before being used in a manufacturing process?
(Choose two)
Response:
A) Installation Qualification (IQ)
B) Initial Qualification (IQ)
C) Performance Qualification (PQ)
D) Environmental Qualification (EQ)
2. Environmental monitoring in sterile areas focuses primarily on:
A) Microbial and particulate levels
B) Humidity only
C) Water use
D) Noise
3. Which of the following best describes a product complaint?
Response:
A) A report of dissatisfaction concerning a company's service.
B) A report of any dissatisfaction with a product's quality, identity, durability, reliability, safety, effectiveness, or performance.
C) A report of a side effect experienced by a patient or consumer using a pharmaceutical product.
D) A report of a financial loss due to the use of a product.
4. The GMP document system includes various types of documents. Which of the following is NOT typically included?
Response:
A) Master plans.
B) Test instructions.
C) Personal employee emails.
D) Manufacturing instructions.
5. When confirming batch records meet requirements, which aspect is NOT typically considered?
Response:
A) The music playlist in the manufacturing area
B) Disposition decisions
C) Review
D) Execution
Solutions:
| Question # 1 Answer: A,C | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: A |
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