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Validation
Services:
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.
Experience:
• 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.
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