Process Validation Protocol - Equipment Qualification Template

• Manufacturer

• Manufacturing Facility
  Address

• Equipment/System

• Protocol Author

• Conducted on

  Date

Equipment Qualification Protocol

• Objective

• Scope

• Responsibility

• Select key items of equipment

  Select Laminar flow Cytotoxic cabinets Bag filler Cream filler Mixing tanks Homogeniser Powder mixer Powder filler Process autoclave Tablet press Encapsulator Blister packer Other

  • Laminar flow
  • Cytotoxic cabinets
  • Bag filler
  • Cream filler
  • Mixing tanks
  • Homogeniser
  • Powder mixer
  • Powder filler
  • Process autoclave
  • Tablet press
  • Encapsulator
  • Blister packer
  • Other

• Specify

• Select utilities supply

  Select Electricity Clean steam boiler Compressed air Nitrogen Other

  • Electricity
  • Clean steam boiler
  • Compressed air
  • Nitrogen
  • Other

• Specify

• Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.

  Media

• Are the user manual and spare parts list available?

  Yes

  No

• Are main components within the preventive maintenance program?

  Yes

  No

• Are primary instruments listed in the calibration program?

  Yes

  No

• Are instrument resolution and accuracy identified and adequate for process control range required?

  Yes

  No

• Are traceable standards used?

  Yes

  No

• Select available SOPs

  Select Operation Configuration Control Disaster Recovery Preventive Maintenance Cleaning Other

  • Operation
  • Configuration Control
  • Disaster Recovery
  • Preventive Maintenance
  • Cleaning
  • Other

• Select environmental requirements

  Select Temperature Humidity Lighting Noise level Electrostatic discharge isolation Other

  • Temperature
  • Humidity
  • Lighting
  • Noise level
  • Electrostatic discharge isolation
  • Other

• Specify

  Select Laminar flow Cytotoxic cabinets Bag filler Cream filler Mixing tanks Homogeniser Powder mixer Powder filler Process autoclave Tablet press Encapsulator Blister packer Other

  • Laminar flow
  • Cytotoxic cabinets
  • Bag filler
  • Cream filler
  • Mixing tanks
  • Homogeniser
  • Powder mixer
  • Powder filler
  • Process autoclave
  • Tablet press
  • Encapsulator
  • Blister packer
  • Other

• Select key processes

  Select Dispensing Gowning Mixing Filling Tableting Encapsulation Freeze drying Container closure Quarantine Release Other

  • Dispensing
  • Gowning
  • Mixing
  • Filling
  • Tableting
  • Encapsulation
  • Freeze drying
  • Container closure
  • Quarantine
  • Release
  • Other

• Specify

Completion

• Equipment Qualification Results

• Conlusions

• Protocol Author & Signature

  Sign

• Departmental Approval by

  Sign

• Quality Assurance Approval by

  Sign