Process Validation
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Questions and Answers

Stage 1 Process Design leads to ______

Evaluate/Confirm Changes

Stage 2 Process Qualification includes Design of Facilities & Qualification of ______

equipment & Utilities

Design qualification (DQ) verifies that all ______ to be met

specifications

Installation qualification (IQ) verifies that equipment has been constructed following the approved ______

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

Operational qualification (OQ) confirms that equipment has met the proper function during qualification of the ______

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

Study Notes

Process Design and Qualification

  • Stage 1 Process Design leads to Process Design Specifications
  • Stage 2 Process Qualification includes Design of Facilities and Qualification of Utilities

Qualification Steps

  • Design qualification (DQ) verifies that all Design Requirements are to be met
  • Installation qualification (IQ) verifies that equipment has been constructed following the approved Design Specifications
  • Operational qualification (OQ) confirms that equipment has met the proper function during qualification of the Operating Ranges

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Description

Quiz on Process Validation - Life Cycle Approach, covering stages such as Process Design, Process Qualification, and Continued Process Verification. Test your knowledge on evaluating changes, designing facilities, qualifying equipment, and more.

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