Biopharmaceutical Quality Quiz
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Questions and Answers

What are the four absolutes of Quality according to Philip Crosby?

  • Conformance to requirements, prevention, zero defects, price of non-conformance (correct)
  • Standardization, automation, optimization, documentation
  • Customer satisfaction, employee motivation, innovation, cost-effectiveness
  • Meeting deadlines, reducing costs, increasing production, minimizing errors
  • What is the role of ICHQ10 in the Biopharmaceutical Industry?

  • Regulating drug pricing
  • Developing and managing Pharmaceutical Quality Systems (correct)
  • Ensuring patent protection
  • Conducting clinical trials
  • Which rules broadly apply to Biopharmaceutical manufacturing?

  • Clinical trial protocols, Drug formulation principles, Marketing strategies
  • FDA regulations, EMA guidelines, ISO standards
  • Supply chain management practices, Human resource policies, Financial accounting standards
  • ICH Quality guidelines, Pharmacopeia, Regional GMP (correct)
  • What is the measurement of quality according to Philip Crosby?

    <p>The price of non-conformance</p> Signup and view all the answers

    What is the system of quality according to Philip Crosby?

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

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