How Well Do You Understand 21st Century Process Validation?

10 Questions | Total Attempts: 71

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How Well Do You Understand 21st Century Process Validation?

Consultants at Pharmatech Associates have authored a quick quiz designed to help you see just how well you understand FDA's recent (sort of) Process Validation guidance and how it applies to your day to day jobs. Please take the test, and, if you have all the answers correct, please send a comment to Pharmaevolution. Com and we will send you a prize (either a Starbuck's gift card or a coffee mug)


Questions and Answers
  • 1. 
    Prior to the recent 2011 process validation guidance, when did FDA issue the previous process validation guidance?
    • A. 

      2001

    • B. 

      1987

    • C. 

      1999

    • D. 

      2003

  • 2. 
    The 2011 PV guidance focuses on the concept of linking product and process development, qualification and continuous monitoring of the production process. 
    • A. 

      True

    • B. 

      False

  • 3. 
    What are the three stages of the process validation lifecycle?
    • A. 

      Process Design, Process Qualification, Continued Process Verification

    • B. 

      Process Design, Commissioning, Validation

    • C. 

      Process Design, Commissioning, Process Qualification

    • D. 

      Commissioning, Process Qualification, Continued Process Verification

  • 4. 
    At what stage of the PV lifecycle are critical process parameters identified?
    • A. 

      Process Design

    • B. 

      Process Qualification

    • C. 

      Continued Process Verification

  • 5. 
    Compared to the previous version of the process validation guidance, which stage is the most significant departure from the classical definition of what constitutes process validation?
    • A. 

      Process Design

    • B. 

      Process Qualification

    • C. 

      Continued Process Verification

  • 6. 
    The range of a process parameter or material attribute established during Stage 1 activities, and the acceptable operating or control range during commercial production is known as:
    • A. 

      Proven Acceptable Range (PAR)

    • B. 

      Control Strategy

    • C. 

      Normal Operating Range

    • D. 

      Quality Release Criteria

  • 7. 
    The objective of Continuous Verification is to:
    • A. 

      Provide the ability to intervene in a process before it drifts out of a state of control

    • B. 

      Allow process and operational improvements to be made without the need to revalidate

    • C. 

      Improve process predictability and product performance

    • D. 

      All of the above

  • 8. 
    Continuous Verification includes all of the following EXCEPT:
    • A. 

      Procedure for continuous improvements to be made

    • B. 

      Identifying the Critical Process Parameters

    • C. 

      Defining rules for making process adjustments

    • D. 

      Defining action/control limits for the process

    • E. 

      Defining action/control limits for the process

  • 9. 
    Process Validation and Process Qualification are interchangeable terms according to the 2011 guidance.
    • A. 

      True

    • B. 

      False

  • 10. 
    Prerequisites to Stage 2 activities must include:
    • A. 

      Validation of facility, utilities and equipment

    • B. 

      Three commercial-scale manufacturing batches

    • C. 

      Annual Product Review (APR) process

    • D. 

      Change-control process

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