Process validation report template checklist
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.
What does this form include?
This form contains 25 sections:
Instructions:1. Identify the impact of each equipment on the product2. Determine its corresponding ri
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
Process(es) subject to process validation
Environmental requirements
Utilities supply
SOPs available
Apparatus/Instrument
Calibration Method
Calibration Date Date
Control Point/Alarm
Output
Calibration
Criteria
Result
Qualification Protocol
Area(s) of Deviation
Requirement/Order
Actual
Justification for Acceptance
Impact on Operation, Function, or Process
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
Use this template