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Citation preview. Pharmaceutical Guidelines DESIGN QUALIFICATION RAPID MIXER GRANULATOR (150 Liters) Document No: PG/DQ/001. Page no 1 of 16The Design Qualification process should address the following points: •. What will be reviewed? (Documented in Validation Plan or DQ protocol). A Design Qualification protocol can be used to verify whether the "off-the-shelf" item will fully deliver the functionality detailed in the URS, and conform to The DQ Protocol documentation includes specification sheets, component and material lists, and drawings that define the basic Cryogenic Freezer and the By the use of a design validation protocol, it is possible to determine if the item will deliver its full functionality based on the URS. It should also conform DQ, IQ, OQ, PQ – gempex offers design, installation, operational and performance qualification. Modest operation that conserves resources is the goal. The form, protocol, or document completed for a DQ should provide sufficient information to identify all of the documents used to verify the design. DQ is to verify that the system has been designed as specified in the URS (User Requirements Specification), FDS (Functional Design Specification), and relevant

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