14/12/22, 14:30 Process Validation Protocol - Equipment Qualification Template Checklist - SafetyCulture

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Title Page
Firmado digitalmente por
ALEXANDER ALEXANDER ANTONIO
ANTONIO CARBALLO CARBALLO PEREZ (FIRMA)
Fecha: 2023.03.30 13:01:38
PEREZ (FIRMA) -06'00'

Manufacturer

Manufacturing Facility 

Equipment/System

Protocol Author

Conducted on 

Process Validation Protocol - Equipment Qualification Template

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Equipment Qualification Protocol

Objective

Scope

Responsibility

Select key items of equipment

Laminar Cytotoxic Bag Cream Mixing Homogeniser Powder Powder Pro

flow cabinets filler filler tanks mixer filler aut

Specify

Select utilities supply

Clean steam Compressed

Electricity boiler air Nitrogen Other

Specify

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Take/attach photos of all relevant equipment drawings such as

mechanical drawings, electrical schematics, process and 
instrument drawings, etc.

Are the user manual and spare parts list available?

Yes No

Are main components within the preventive maintenance program?

Yes No

Are primary instruments listed in the calibration program?

Yes No

Are instrument resolution and accuracy identified and adequate for process control
range required?

Yes No

Are traceable standards used?

Yes No

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Select available SOPs

Disaster Preventive
Operation Configuration Recovery Maintenance Cleaning Other
Control

Select environmental requirements

Electrostatic
Temperature Humidity Lighting Noise discharge isolation Other
level

Specify

Laminar Cytotoxic Bag Cream Mixing Homogeniser Powder Powder Pro

flow cabinets filler filler tanks mixer filler aut

Select key processes

Dispensing Gowning Mixing Filling Tableting Encapsulation Freeze Contain

drying closure

Specify

Completion

Equipment Qualification Results

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Conlusions

Protocol Author & Signature 

Departmental Approval by 

Quality Assurance Approval by 

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's
solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice.
You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. Any ratings
or scores displayed in our Public Library have not been verified by SafetyCulture for accuracy. Users of our platform may provide a rating or score
that is incorrect or misleading. You should independently determine whether the template is suitable for your circumstances. You can use our
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