Template Information
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.
Category: general
Template Questions
- Instructions:1. Identify the impact of each equipment on the product2. Determine its corresponding ri
- Equipment Criticality & Risk Assessment
- 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