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