12/16/2023 Process Validation Report Template - Download FREE Template | Lumiform Templates
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Process Validation Report Template
Directions: 1. Identify the influence of each tool on the product 2. Define its corresponding risk priority
and attach suitable photos. 3. Define qualification protocol such as environmental demands, utility
supply, SOPs ready, calibration devices, acceptance criteria vs. performance test results, and fields of
variation. 4. Describe conclusions on the efficacy of the devices/system 5. Finish this template with
digital signatures of the validation manager, head of quality assurance and production officer
Equipment Criticality & Risk Assessment
Mixing Tanks
Direct Impact Indirect Impact Safety Impact No Impact
Raw Material and Consumable Refrigerators and Freezers
Direct Impact Indirect Impact Safety Impact No Impact
Toxic Gas Detectors
Direct Impact Indirect Impact Safety Impact No Impact
Pipettes
Direct Impact Indirect Impact Safety Impact No Impact
Product Transfer Pumps
Direct Impact Indirect Impact Safety Impact No Impact
Unfiltered HVAC System
Direct Impact Indirect Impact Safety Impact No Impact
https://lumiformapp.com/templates/process-validation-report-template_16498
12/16/2023 Process Validation Report Template - Download FREE Template | Lumiform Templates
Dust Extraction
Direct Impact Indirect Impact Safety Impact No Impact
Trolleys
Direct Impact Indirect Impact Safety Impact No Impact
Laminar Flow and Safety Cabinets
Direct Impact Indirect Impact Safety Impact No Impact
Safety Barriers
Direct Impact Indirect Impact Safety Impact No Impact
Scissors/Clamps
Direct Impact Indirect Impact Safety Impact No Impact
Emergency Stops
Direct Impact Indirect Impact Safety Impact No Impact
Retort Stands
Direct Impact Indirect Impact Safety Impact No Impact
Product Storage Refrigerators and Freezers
Direct Impact Indirect Impact Safety Impact No Impact
Personal Protection Equipment
Direct Impact Indirect Impact Safety Impact No Impact
Filling Equipment
Direct Impact Indirect Impact Safety Impact No Impact
Production Balances
Direct Impact Indirect Impact Safety Impact No Impact
Autoclaves
Direct Impact Indirect Impact Safety Impact No Impact
Centirfuges
Direct Impact Indirect Impact Safety Impact No Impact
https://lumiformapp.com/templates/process-validation-report-template_16498
12/16/2023 Process Validation Report Template - Download FREE Template | Lumiform Templates
Fire Suppression Systems
Direct Impact Indirect Impact Safety Impact No Impact
Process Water Generators
Direct Impact Indirect Impact Safety Impact No Impact
Automated Cleaning Equipment
Direct Impact Indirect Impact Safety Impact No Impact
Filtered HVAC Systems
Direct Impact Indirect Impact Safety Impact No Impact
Manual Cleaning Equipment
Direct Impact Indirect Impact Safety Impact No Impact
Qualification Protocol
Method(s) to process confirmation
Dispensing Gowning Mixing Filling Tableting Encapsulation
Freeze drying Container closure Quarantine Release Other
Environmental demands
Temperature Humidity Lighting Noise level
Electrostatic discharge isolation Other
Utilities supply
Compressed air Nitrogen Electricity Clean steam boiler Other
SOPs available
Configuration control Preventive Maintenance Operation Disaster Recovery
Cleaning Other
Calibration Equipment
Calibration process
https://lumiformapp.com/templates/process-validation-report-template_16498
12/16/2023 Process Validation Report Template - Download FREE Template | Lumiform Templates
Calibration date and time:
Instrument/Device:
Results
Calibration
Control/Monitor point
Describe the output
Acceptance Criteria and Performance Test Results
Acceptance criteria
Performance test results
Decision
Pass Fail
https://lumiformapp.com/templates/process-validation-report-template_16498
12/16/2023 Process Validation Report Template - Download FREE Template | Lumiform Templates
Area(s) of Deviation
Model/Serial number Handbook Writing SOP (Operation)
SOP (Maintenance) SOP (Calibration) In-/Output control
Test equipment of instruments Utilities and service Specification Drawing
Power Environment Other None
Completion
Qualification Protocol Results
Results of the validity of the devices/system
Full name & signature of Production Officer:
Full name & signature of Validation Manager:
Full name & signature Head of Quality Assurance:
Please note that this checklist template is a hypothetical example and provides only standard information. The template does not aim to replace,
among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek
your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
https://lumiformapp.com/templates/process-validation-report-template_16498
