Master the Art of Regulatory Inspections
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Questions and Answers

Which of the following is NOT a reason for conducting inspections?

  • Assessing compliance of rules and regulations
  • Determining the frequency of inspections (correct)
  • Evaluating the effectiveness of a pharmaceutical establishment
  • Identifying serious lapses in operations

What is the purpose of a comprehensive inspection?

  • To determine the frequency of inspections
  • To identify serious lapses in operations
  • To assess compliance of a new pharmaceutical establishment (correct)
  • To evaluate the effectiveness of an existing pharmaceutical establishment

When should an inspection be announced?

  • For routine inspections (correct)
  • For inspections of new establishments
  • For inspections of existing establishments
  • For inspections of serious lapses

What factors may dictate the frequency of inspections?

<p>The risk level of the establishment (A)</p> Signup and view all the answers

When are concise inspections typically conducted?

<p>For inspections of serious lapses (C)</p> Signup and view all the answers

Which of the following is NOT a type of inspection?

<p>Post-approval inspection (C)</p> Signup and view all the answers

When are inspections typically conducted?

<p>During the compliance process (C)</p> Signup and view all the answers

What may dictate the frequency of inspections?

<p>Risk-based considerations (C)</p> Signup and view all the answers

Which type of inspection is generally used for a new pharmaceutical establishment applying for a permit/license?

<p>Comprehensive inspection (C)</p> Signup and view all the answers

What is an important tool for assessing compliance of rules, regulations, or laws?

<p>Inspections (C)</p> Signup and view all the answers

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