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Module 11 - Process Validation Report Template
Module 11 - Process Validation Report Template
Allen Kent L. Inquit

Module 11 - Process Validation Report Template

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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Free Module 11 - Process Validation Report Template Checklist

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Title Page

  • Site conducted

  • Manufacturer

  • Manufacturing Facility

  • Equipment/System

  • Protocol Author

  • Conducted on

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

    • Dispensing
    • Gowning
    • Mixing
    • Filling
    • Tableting
    • Encapsulation
    • Freeze drying
    • Container closure
    • Quarantine
    • Release
    • Other

  • Specify

  • Environmental requirements

    • Temperature
    • Humidity
    • Lighting
    • Noise level
    • Electrostatic discharge isolation
    • Other

  • Specify

  • Utilities supply

    • Electricity
    • Clean steam boiler
    • Compressed air
    • Nitrogen
    • Other

  • Specify

  • SOPs available

    • Operation
    • Configuration Control
    • Disaster Recovery
    • Preventive Maintenance
    • Cleaning
    • Other

  • 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

    • Model/Serial No.
    • Specification
    • Manual
    • Drawing
    • Wiring/Cabling
    • Power/Fusing
    • SOP (Operation)
    • SOP (Maintenance)
    • SOP (Calibration)
    • Input/Output Control
    • Environment
    • Test Equipment of Instruments
    • Utilities and Service
    • Spare Parts List, Part Number and Supplier
    • Other
    • None
    • 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

Module 11 - Process Validation Report Template
Allen Kent L. Inquit

Module 11 - Process Validation Report Template

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.

Use this Template
The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.

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