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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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:
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.
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