1 - Equipment Validation Services.
2 - Utility Systems Validation.
3 - Facility Qualification..
4 - Computer System Validation.
5 - Clean Zones Qualification.
1 - Equipment validation services:
We have engaged in CGMP related services in pharmaceutical field for over 15 years, having some experts with abundant experience and advanced testing apparatus. We can provide consultation service and assist you in European or American CGMP compliance.
Our validation scope includes:
Sterilization equipments, sterilizing tunnel and sterile filling systems
Freeze-dryer and other pharmaceutical equipments .
2 - Utility Systems Validation:
- HVAC Systems.
- Purified Water Systems.
- WFI Water Systems.
- Clean Steam Systems.
- Clean In Place Systems.
- Steam In Place Systems.
- Special Gases Systems.
3 - Facility Qualification:
- Installation Qualification (IQ).
- Operational Qualification (OQ) and, as appropriate Performance Qualification (PQ) Protocols.
- A master plan will be prepared for each new facility. An IQ and OQ will be prepared for all services and equipment, while a PQ will be prepared only for those systems or processes that require performance data for verifying proper operation.
4 - Computer System Validation:
Our computer engineers have extensive experience in the validation of integrated software and hardware systems Whether the system is process control or data acquisition, PLC- or PC-based, our computer software specialists are able to verify and document that your system is CGMP compliant.
Our capabilities include the following:
- Software quality assurance program development and audits.
- Systems requirements document development.
- Functional specifications development.
- Qualification protocol preparation and execution.
- Programmable Logic Controllers (PLCs).
- Supervisory Control and Data Acquisition (SCADA).
- Building Management/Automation System (BMS/BAS).
- Process Automation/Control Systems (PAS/PCS).
- Laboratory Data Acquisition.