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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 product2. 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/system5. 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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