Process Validation Protocol - Operational Qualification Template

• Manufacturer

• Manufacturing Facility
  Address

• Equipment/System

• Protocol Author

• Conducted on

  Date

Operational Qualification Protocol

• Objective

• Scope

• Responsibility

Materials, Equipment, Documents

Preparation

List of Calibration Equipment Required

• Apparatus/Instrument

• Calibration Method

• Calibration Date

  Date
Document Check

• SOP Title and Number

• File Location

• QA/QC Approval Date

  Date
Training Records

• Course on SOP#

• Staff Name

• Date

  Date
Equipment

• Equipment Make and Model

• Is a manual available?

  Yes

  No

Results

Control Points and Alarms

• Control Point/Alarm

• Result

• Date

  Date
Outputs

• Output

• Result

• Date

  Date
Calibration of Equipment/System

• Calibration SOP

• Result

• Date

  Date

Specific Challenge of the Equipment or System

• Test in Normal Conditions

• Test of Worst Case Situation

Completion

• Operational Qualification Results

• Conclusions

• Protocol Author & Signature

  Sign

• Departmental Approval by

  Sign

• Quality Assurance Approval by

  Sign