QUESTION: 21

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

Ask the vendor to take responsibility.
Document and perform audits.
Request an inspection from a regulatory authority.
Request documentation from the sub-contractor.

Answer(s): B

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QUESTION: 22

A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

Certificate of GMP
Certificate of Free Sale
Certificate of Pharmaceutical Product
Certificate of Analysis for the finished product

Answer(s): C

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QUESTION: 23

What is the LAST stage in the development of a quality risk management process for a medical device?

Risk analysis
Risk reduction
Risk acceptance
Risk evaluation

Answer(s): C

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QUESTION: 24

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

ISO 14971 risk analysis
Failure mode and effect analysis
Fault tree analysis
Hazard and operability study

Answer(s): A

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Free RAC-US Exam Braindumps (page: 7)

QUESTION: 21

QUESTION: 22

QUESTION: 23

QUESTION: 24

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