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Process Validation Report Template

Instructions:
1. Identify the impact of each equipment on the product
2. Determine its corresponding risk priority and add relevant photos by tapping the image icon
3. Specify qualification protocol such as environmental requirements, utilities supply, SOPs available, calibration equipment, acceptance criteria vs. performance test results, and areas of deviation.
4. Describe conclusions on the validity of the equipment/system and create actions by tapping the action icon
5. Sign of with digital signatures of the validation manager, head of quality assurance and production officer

Equipment Criticality & Risk Assessment

Mixing Tanks

Risk Priority

Raw Material and Consumable Refrigerators and Freezers

Risk Priority

Toxic Gas Detectors

Risk Priority

Pipettes

Risk Priority

Product Transfer Pumps

Risk Priority

Unfiltered HVAC System

Risk Priority

Dust Extraction

Risk Priority

Trolleys

Risk Priority

Laminar Flow and Safety Cabinets

Risk Priority

Safety Barriers

Risk Priority

Scissors/Clamps

Risk Priority

Emergency Stops

Risk Priority

Retort Stands

Risk Priority

Product Storage Refrigerators and Freezers

Risk Priority

Personal Protection Equipment

Risk Priority

Filling Equipment

Risk Priority

Production Balances

Risk Priority

Autoclaves

Risk Priority

Centirfuges

Risk Priority

Fire Suppression Systems

Risk Priority

Process Water Generators

Risk Priority

Automated Cleaning Equipment

Risk Priority

Filtered HVAC Systems

Risk Priority

Manual Cleaning Equipment

Risk Priority

Qualification Protocol
Process(es) subject to process validation

Specify

Environmental requirements

Specify

Utilities supply

Specify

SOPs available

Specify

Calibration Equipment

Apparatus/Instrument

Calibration Method

Calibration Date
Results

Control Point/Alarm

Output

Calibration

Acceptance Criteria Vs. Performance Test Results

Criteria

Result

Decision

Area(s) of Deviation
Deviations

Requirement/Order

Actual

Justification for Acceptance

Impact on Operation, Function, or Process

Completion

Qualification Protocol Results

Conclusions on the validity of the equipment/system

Production Officer Name & Signature
Validation Manager Name & Signature
Head of Quality Assurance Name & Signature

Process Validation Report Template Checklist

Created by: SafetyCulture Staff | Industry: General | Downloads: 48

A process validation report template is used by validation managers in the pharmaceutical manufacturing industry to properly document qualification protocol and ensure compliance with FDA regulations. This process validation report templates has been designed to make it easier for validation managers to perform equipment criticality and risk assessment, compare acceptance criteria against performance test results, and specify areas of deviation.

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Process Validation Report Template

Instructions:
1. Identify the impact of each equipment on the product
2. Determine its corresponding risk priority and add relevant photos by tapping the image icon
3. Specify qualification protocol such as environmental requirements, utilities supply, SOPs available, calibration equipment, acceptance criteria vs. performance test results, and areas of deviation.
4. Describe conclusions on the validity of the equipment/system and create actions by tapping the action icon
5. Sign of with digital signatures of the validation manager, head of quality assurance and production officer

Equipment Criticality & Risk Assessment

Mixing Tanks

Risk Priority

Raw Material and Consumable Refrigerators and Freezers

Risk Priority

Toxic Gas Detectors

Risk Priority

Pipettes

Risk Priority

Product Transfer Pumps

Risk Priority

Unfiltered HVAC System

Risk Priority

Dust Extraction

Risk Priority

Trolleys

Risk Priority

Laminar Flow and Safety Cabinets

Risk Priority

Safety Barriers

Risk Priority

Scissors/Clamps

Risk Priority

Emergency Stops

Risk Priority

Retort Stands

Risk Priority

Product Storage Refrigerators and Freezers

Risk Priority

Personal Protection Equipment

Risk Priority

Filling Equipment

Risk Priority

Production Balances

Risk Priority

Autoclaves

Risk Priority

Centirfuges

Risk Priority

Fire Suppression Systems

Risk Priority

Process Water Generators

Risk Priority

Automated Cleaning Equipment

Risk Priority

Filtered HVAC Systems

Risk Priority

Manual Cleaning Equipment

Risk Priority

Qualification Protocol
Process(es) subject to process validation

Specify

Environmental requirements

Specify

Utilities supply

Specify

SOPs available

Specify

Calibration Equipment

Apparatus/Instrument

Calibration Method

Calibration Date
Results

Control Point/Alarm

Output

Calibration

Acceptance Criteria Vs. Performance Test Results

Criteria

Result

Decision

Area(s) of Deviation
Deviations

Requirement/Order

Actual

Justification for Acceptance

Impact on Operation, Function, or Process

Completion

Qualification Protocol Results

Conclusions on the validity of the equipment/system

Production Officer Name & Signature
Validation Manager Name & Signature
Head of Quality Assurance Name & Signature