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Process Validation Report Template

Validation managers in the pharmaceutical industry use such a template for process validation to document everything properly. In this way, they ensure that the regulations are adhered to. This process validation report template is designed to make it easier for validation managers to perform equipment testing and risk assessment, compare acceptance criteria with performance test results, and define ranges of variation.

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Process Validation Report Template

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
Raw Material and Consumable Refrigerators and Freezers
Toxic Gas Detectors
Pipettes
Product Transfer Pumps
Unfiltered HVAC System
Dust Extraction
Trolleys
Laminar Flow and Safety Cabinets
Safety Barriers
Scissors/Clamps
Emergency Stops
Retort Stands
Product Storage Refrigerators and Freezers
Personal Protection Equipment
Filling Equipment
Production Balances
Autoclaves
Centirfuges
Fire Suppression Systems
Process Water Generators
Automated Cleaning Equipment
Filtered HVAC Systems
Manual Cleaning Equipment

Qualification Protocol

Method(s) to process confirmation
Environmental demands
Utilities supply
SOPs available

Calibration Equipment

Calibration process
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
Area(s) of Deviation

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:
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