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.

Title Page

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
Apparatus/Instrument
Calibration Method
Calibration Date
Control Point/Alarm
Output
Calibration
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
Requirement/Order
Actual
Justification for Acceptance
Impact on Operation, Function, or Process