Quality Guidelines in Pharmaceutical Products Quiz
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Questions and Answers

Which organization is responsible for harmonizing technical requirements for pharmaceuticals?

  • ISO
  • PICS (correct)
  • WHO
  • ASEAN
  • What does ICH stand for in the context of pharmaceuticals?

  • International Council for Harmonisation (correct)
  • Institute for Clinical Health
  • International Council for Healthcare
  • Institute for Chemical Handling
  • Which Quality Management System standard is mentioned in the text?

  • ISO 45001:2018
  • ISO 27001:2013
  • ISO 9001:2015 (correct)
  • ISO 14001:2015
  • What does FEFO stand for in the context of pharmaceuticals?

    <p>First Expiry, First Out</p> Signup and view all the answers

    Which organization is associated with the guideline on good practices like GMP and GSP?

    <p>WHO</p> Signup and view all the answers

    What does GDP stand for in the context of pharmaceutical quality guidelines?

    <p>Good Distribution Practices</p> Signup and view all the answers

    What is the purpose of ISO 31000:2018 Risk Management Guidelines?

    <p>To outline principles for managing risk within an organization</p> Signup and view all the answers

    Which of the following is NOT one of the Quality Management Principles mentioned in the text?

    <p>Innovation Management</p> Signup and view all the answers

    What aspect does the Engagement of People principle in Quality Management focus on?

    <p>Collaboration and participation</p> Signup and view all the answers

    Which organization developed the ISO 31000:2018 Risk Management Guidelines?

    <p>ISO - International Organization for Standardization</p> Signup and view all the answers

    What does the Process Approach principle in Quality Management emphasize?

    <p>Guidelines and policies in managing processes</p> Signup and view all the answers

    Under which UN agency does WHO - World Health Organization operate?

    <p>United Nations (UN)</p> Signup and view all the answers

    What do the letters 'ICH' stand for in the context of pharmaceuticals?

    <p>International Council for Harmonisation</p> Signup and view all the answers

    Which phase of clinical testing involves patients with a disease and focuses on both safety and efficacy?

    <p>Phase III</p> Signup and view all the answers

    What is the mission of the Pharmaceutical Inspection Co-operation Scheme (PICS)?

    <p>To harmonize GMP standards and quality systems</p> Signup and view all the answers

    What does the abbreviation CPR stand for in the pharmaceutical context?

    <p>Certificate Product Registration</p> Signup and view all the answers

    In the context of pharmaceuticals, what does the term 'Biotechnological' refer to?

    <p>Medicines derived from animals &amp; humans</p> Signup and view all the answers

    What is the main focus of ISO 31000:2018 Risk Management Guidelines within pharmaceutical Quality Management Principles?

    <p>Maintaining regulatory compliance and safety standards</p> Signup and view all the answers

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