GMP Documentation and Validation in Pharmaceutical Technology
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Questions and Answers

What is the main focus of Lecture 4: GMP; Documentation and Validation?

  • Validation principles (correct)
  • Standard operating procedures
  • Premises and Personnel Documentation
  • Calibration and Verification

    • Which ILO involves recommending the correct validation or qualification approaches for specific processes?

  • Communicating clearly by verbal means
  • Recalling and specifying used terminology
  • Evaluating process from industrial case studies (correct)
  • Classifying the types of documentation

    • What is the key difference between validation and qualification according to the lecture outline?

  • Calibration and Verification
  • Verification principles
  • Validation principles (correct)
  • Change Control

    • Which part of the pharmaceutical industry does the course mainly aim to improve quality systems within?

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

    What is the primary goal of Change Control in the context of GMP and QMS?

    <p>To control and manage changes effectively</p> Signup and view all the answers

    Which ILO involves recalling and specifying terminology used in quality systems within the pharmaceutical industry?

    <p>Recalling and specifying used terminology</p> Signup and view all the answers

    What are the three main levels of classification for areas in a pharmaceutical facility based on protection?

    <p>General, Protected, Controlled</p> Signup and view all the answers

    Which of the following are typical HVAC system parameters that should be qualified for a pharmaceutical facility?

    <p>Temperature and Relative humidity, Microbiological air and surface counts</p> Signup and view all the answers

    What must documentation in a pharmaceutical facility be approved, signed and dated by?

    <p>Authorized person</p> Signup and view all the answers

    What does the term 'specifications' refer to in a pharmaceutical facility?

    <p>List of tests, analytical procedures, storage conditions, and acceptance criteria</p> Signup and view all the answers

    What is the purpose of a Controlled Area in a pharmaceutical facility?

    <p>To define specific environmental conditions to prevent contamination or degradation</p> Signup and view all the answers

    What are some typical examples of areas classified as Level 1 in a pharmaceutical facility?

    <p>Warehousing, secondary packing</p> Signup and view all the answers

    Which of the following is NOT a typical parameter that should be qualified for a pharmaceutical facility's HVAC system?

    <p>Employee coffee consumption rates</p> Signup and view all the answers

    What type of personnel should be qualified and trained for safety and hygiene in a pharmaceutical facility?

    <p>Qualified/Trained Safety Hygiene Personnel</p> Signup and view all the answers

    What is the main source for auditing and inspection by quality personnel in a pharmaceutical facility?

    <p>Approved, signed and dated documentation</p> Signup and view all the answers

    What does 'documentation' serve as in a pharmaceutical facility?

    <p>Main source for auditing and inspection by quality personnel</p> Signup and view all the answers

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