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Process Validation Report Template

Assessment managers in the pharmaceutical industry use this process validation report template to document everything properly. It 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
Product Transfer Pumps
Unfiltered HVAC System
Dust Extraction
Laminar Flow and Safety Cabinets
Safety Barriers
Emergency Stops
Retort Stands
Product Storage Refrigerators and Freezers
Personal Protection Equipment
Filling Equipment
Production Balances
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:


Control/Monitor point
Describe the output

Acceptance Criteria and Performance Test Results

Acceptance criteria
Performance test results
Area(s) of Deviation


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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Simplify Process Validation with Customizable Report Template

A process validation report template is a document used to provide a structured report of a process validation effort. It is used to provide a comprehensive overview of the process validation activities, including objectives, scope, methodology, results, and conclusions. The report is typically used to document the results of a validation effort to provide evidence that a process is capable of consistently producing a product or service that meets specified requirements. The template includes sections for the introduction, scope, methodology, results, conclusions and recommendations. The introduction usually includes background information about the process, the scope defines what will be covered in the validation effort, the methodology outlines the methods used to validate the process,. In the end of the audit you can access a auto-generated report which will contain the results of the validation, and the conclusions and recommendations summarize the validation results and provide suggestions for any necessary changes.

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