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

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

<p>WHO (A)</p> Signup and view all the answers

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

<p>Good Distribution Practices (B)</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 (A)</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 (D)</p> Signup and view all the answers

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

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

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

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

What does the Process Approach principle in Quality Management emphasize?

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

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

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

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

<p>International Council for Harmonisation (B)</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 (A)</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 (B)</p> Signup and view all the answers

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

<p>Certificate Product Registration (B)</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 (A)</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 (A)</p> Signup and view all the answers

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