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Process Validation Checklist

Process Validation Checklist

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hithamextrastep
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225 views2 pages

Process Validation Checklist

Process Validation Checklist

Uploaded by

hithamextrastep
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
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LY iAuditor Cone your paper celts by soferyculeure digital forms Process Validation Protocol - Equipment Qualification Template Equipment Qualification Protocol Objective Scope Responsibility Select key items of equipment Laminar flow Cytotoxic cabinets Bag filler Cream filler Mixing tanks. Powder mixer Powder filler Process autoclave Tablet press Encapsulator Blister packer Other Homogeniser Select utilities supply Electricity Clean steam boiler Compressedair Nitrogen Other, Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc. Media ‘Are the user manual and spare parts list available? Yes No ‘Are main components within the preventive maintenance program? Yes No ‘Ate 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 Select available SOPs Operation Configuration Control__—‘Disaster Recovery Preventive Maintenance Other Cleaning Select environmental reauirements

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