First, explain how you would validate the following aspects of a GMP plant: Facilities, Utilities, Equipment, Computer Control Systems, Methods, Operators.  Which of the listed features fits into these categories? How do you qualify the design, installation, operation, process, and/or re-qualify each of the listed features in the homework. Second, describe how you would write protocols designed to validate each feature. 


(A new, hypothetical GMP plant has the following features:

  1. Incoming       warehouse for ingredients and components
  2. Outgoing       warehouse for storage and shipping of final product
  3. Employee       cafeteria
  4. Quality       Control laboratory and test instruments
  5. Air       handling system for production areas
  6. Air       handling system for office areas
  7. Production       equipment
  8. Maintenance       shop
  9. Nitrogen,       compressed air and vacuum systems for manufacturing areas.
  10. A       product to be manufactured
  11. Test       methods to evaluate the product
  12. Office       area for production manager
  13. Office       area for accounting people
  14. Manufacturing       area

1) Describe how this plant should be validated. Include those features above that require validation. Where appropriate, indicate the sequence that should be followed. 

2) Describe the types of protocols that should be required for each feature discussed.

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