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Template for Design Qualification Protocol

 Pharma Editor
 October 26, 2016
 Validation & Qualification
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Template for Design Qualification Protocol

OBJECTIVE

To design, engineer, and supply the Name of Equipment and to provide assurance that the machine is
manufactured as per the URS:  Doc Number and it complies with the Scope of Supply. To prove that each

operation proceeds as per the design qualification and the tolerances prescribed there in the document,
are the same at utmost transparency.

SCOPE

The scope of this qualification document is limited to the Design Qualification of Name of Equipment.

This qualification document is part of a validation activity for the Name of Equipment.

RESPONSIBILITIES

CLIENT

To Check and Approve the design qualification.

MANUFACTURER

To design, engineer and provide the complete technical details of the equipment pertaining to its design
qualification viz.

Machine overview,

General arrangement drawing,

Equipment
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Specifications
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Material of construction of all components

Safety features and alarms

To ensure the proper installation and commissioning of the equipment.

To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in
time, any change is desired in the mutually agreed design, Change control procedure shall be followed
and documented.

To confirm the safe delivery of the equipment to the user site.

MACHINE DESCRIPTION

(Details of Equipment shall be written here)

TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS

Description Specification

(Note: The rows shall be increased as per no of components.)

MATERIAL OF CONSTRUCTION

Description Specification

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 (Note: The rows shall be increased / decreased as per requirement.)

CHANGE CONTROL PROCEDURE

Change in the agreed design shall be addressed through the well-defined Change control procedure.

DESIGN QUALIFICATION REPORT

LIST OF ABBREVIATIONS(The rows shall be increased / decreased as per requirement.)

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