DQ (Design Qualification)

PURPOSE
DQ is to verify that the system has been designed as specified in the URS (User
Requirements Specification), FDS (Functional Design Specification), and relevant
equipment specifications satisfying all GMP requirements. The Process User
Requirements in the URS have been identified by the Quality Risk Assessment.
Since the Quality Risk Assessment is an iterative process, it may be performed
again, whenever necessary, during the DQ and subsequent lifecycle qualifications.
For hardware and software of the control system, verification data will be collected
to prove that the system has been designed in accordance with the URS and FDS
including the requirements of 21 CFR Part 11. As DQ is the final step to formally
review and document the proper design of the system, the protocol must enable
the reviewers to verify that all quality-critical attributes and essential technical
attributes of the system have been incorporated in the design. When the DQ report
is approved, the system is ready for fabrication and construction.

IQ (Installation Qualification)

PURPOSE
IQ is to verify that the system has been installed as specified in the design,
satisfying all process, utility and environment requirements. For hardware and
software of the control system, verification data will be collected to prove that the
proper control system has been installed as specified in the design including the
requirements of 21 CFR Part 11. As IQ is the final step to formally audit and
document proper installation of the system, this protocol should enable the
reviewers to verify proper installation of all quality-critical components of the
system. Prior to this IQ, all installation inspections and functional testing for the
system must have been completed in coordination with the engineering
department, construction companies and equipment suppliers through FAT
(Factory Acceptance Test), SAT (Site Acceptance Test), and the subsequent
testing activities during Commissioning. Any of the test data can be used as the
evidence of IQ, only if such plan and data were approved through the cGMP
procedures. When the IQ report is approved, the system is ready for the execution
of OQ.

OQ (Operational Qualification)

PURPOSE
OQ is to verify that the system operates as specified in the design, satisfying all
functional requirements. This protocol will enable the reviewers to verify that all
functional testing of the quality-critical equipment and components including the
requirements of 21 CFR Part 11 has been performed and the verification data have
been collected and attached to this OQ report. OQ is the final step to formally audit
and document proper operation of the system. All functional testing for the system
must have been completed in coordination with the engineering department and
equipment suppliers prior to this OQ through FAT (Factory Acceptance Test), SAT
(Site Acceptance Test), and the subsequent testing activities during
Commissioning. Any of the test data can be used as the evidence of OQ, only if
such plan and data were approved through the cGMP procedures. When the OQ
report is approved, the system is ready for the execution of PQ.

PQ (Performance Qualification)

PURPOSE
PQ is to verify that the system performance satisfies all requirements including the
critical quality attributes and critical process parameters, that have been identified
by the Quality Risk Assessment, as specified in the URS (User Requirements
Specification). The performance requirements and acceptance criteria are defined
in the PQ protocol for the systems requiring GMP compliance such as the clean
utility systems, HVAC and cleanroom systems, and sterilizers. (The performance of
the process systems and cleaning systems will be verified in the process validation
and cleaning validation that are not in the scope of this PQ). The performance tests
will be made under the actual production conditions, and the verification data will
be collected and attached to this PQ report. PQ is the final step to formally test and
document proper performance of the system prior to normal operation. When the
final PQ report is approved, the system is ready for normal production operation.

SYSTEM DESCRIPTION

The HVAC System is designed to serve the laboratory suite of the biotechnology
plant including cell culture rooms, aseptic rooms, preparation rooms, and air locks.
The laboratory rooms are designed for Class 10,000 and the air locks for Class
100,000. Corridors are controlled but unclassified areas. Clean benches in the
Class 10,000 laboratory rooms are designed for Class 100. The outside air,
combined with the return air, is treated by AHU-101 and supplied to the laboratory
area. A part of the air exiting from the laboratory rooms is directly exhausted into
the atmosphere by an exhaust fan, while the remaining air is re-circulated to the
AHU as return air by a return fan. The air entering the AHU is filtered by pre-filters
and medium filters and then air conditioned for humidity and temperature control,
and is supplied to the laboratory area by a supply fan at desired pressure. The
supply air is terminal filtered by HEPA filers at the entrance to the cleanrooms. The
system is designed to satisfy all cGMP requirements.