What Documentation Will You Receive from AIPAK Engineering?
| Document / Service | Purpose | Project Stage |
|---|---|---|
| URS Review | Confirm user and process requirements | Planning |
| DQ | Verify design meets project requirements | Design |
| FAT | Verify equipment performance before shipment | Factory |
| IQ | Verify correct installation | Installation |
| OQ | Verify operating functions and parameters | Commissioning |
| PQ | Verify consistent process performance | Production |
| SAT | Verify performance at customer site | Site |
| Operation Manual | Guide operators on machine operation | Delivery |
| Maintenance Manual | Support preventive and corrective maintenance | Delivery |
| Electrical Drawings | Support electrical installation and troubleshooting | Engineering |
| P&ID / Layout | Support process and utility integration | Engineering |
| Spare Parts List | Support maintenance planning | Delivery |
| Training Documents | Support operator and maintenance training | Commissioning |
DQ, IQ, OQ and PQ Validation for Pharmaceutical Equipment
DQ
Design Qualification
What does DQ verify?
DQ verifies that the proposed equipment and system design meets the agreed User Requirement Specification (URS), process requirements and applicable project standards.
IQ
Installation Qualification
What does IQ verify?
IQ verifies that the equipment, components, utilities and installation are installed according to approved drawings, specifications and manufacturer requirements.
OQ
Operational Qualification
What does OQ verify?
OQ verifies that the equipment operates correctly within the defined operating ranges and that critical functions and controls perform as intended.
PQ
Performance Qualification
What does PQ verify?
PQ verifies that the complete system consistently performs according to the defined process requirements under actual or simulated production conditions.
Factory Acceptance Test & Site Acceptance Test
Design
Process and engineering design based on your product, capacity and regulatory requirements.
- User Requirement Specification (URS)
- Process flow design (PFD / P&ID)
- Equipment specification
- Cleanroom & utility layout
- Design Qualification (DQ)
- GMP compliance review
Manufacturing
Equipment is manufactured and assembled under quality control at our factory.
- Material & component sourcing (316L, certified parts)
- Fabrication & assembly
- In-process quality checks
- Component traceability
- Pre-FAT internal testing
FAT
Equipment is tested at the manufacturing site against agreed specifications and FAT protocols before shipment.
- Mechanical inspection
- Electrical inspection
- PLC/control system testing
- Alarm and interlock testing
- Process parameter verification
- Safety function testing
- Documentation review
Shipment
Equipment is packed, protected and shipped to your site with customs support.
- Export packing & protection
- Loading & container securing
- Shipping documentation
- Customs & logistics coordination
- Delivery to site
Installation
Equipment is positioned, assembled and connected at your facility.
- Positioning & leveling
- Mechanical assembly
- Utility connection (power, water, air, steam)
- Line integration
- Pre-commissioning checks
SAT
SAT verifies that the equipment has been correctly installed, integrated and operated at the customer's site.
- Installation verification
- Utility connection
- System integration
- Trial operation
- Performance checks
- Operator training
- Site documentation
Validation
Qualification to confirm the line is installed, operates and performs as required, to GMP.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- 21 CFR Part 11 / data integrity
- Validation documentation package
- Audit support
Production
Hand-over to routine GMP production with ongoing support.
- Batch production support
- Final documentation hand-over
- Operator & maintenance training
- After-sales & spare parts
- Remote / on-site support
Complete Pharmaceutical Validation Documentation Package
Engineering Documents
General Arrangement Drawing
Layout Drawing
P&ID
Utility Requirements
Electrical Drawings
Component List
Equipment Specifications
Qualification Documents
Testing Documents
FAT Protocol
FAT Report
SAT Protocol
SAT Report
Operation & Maintenance
Operation Manual
Maintenance Manual
Troubleshooting Guide
Spare Parts List
Preventive Maintenance Schedule
Quality Documents
Material Certificates
Calibration Certificates
Component Certificates
Welding Documentation
Surface Finish Documentation
Inspection Records
DQ, IQ, OQ and PQ Validation for Pharmaceutical Equipment
Why Validation Documentation Matters
Without Proper Documentation
With AIPAK Documentation
Need a Validation Documentation Package for Your Pharmaceutical Project?
Tell us your product, production capacity and project requirements. Our engineering team can prepare the appropriate documentation and qualification plan for your equipment or turnkey production line.