DQ (Design Qualification)

PURPOSE
DQ is to verify that the system has been designed as specified in the URS (User Requirement Specification), FDS
(Functional Design Specification) and relevant equipment specifications satisfying all GMP requirements. 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.

DQ PROTOCOLS
        PROCESS EQUIPMENT AND SYSTEMS
                Media Preparation and Hold Tanks
                Buffer Preparation and Hold Tanks
                Process Tanks
                Reactors – Organic Synthesis
                Bioreactors
                Evaporator Systems
                Distillation Tower Systems

        CLEAN UTILITY SYSTEMS

                USP Purified Water Storage and Distribution Systems
                WFI Storage and Distribution Systems
                Clean Steam Generation and Distribution Systems 
                Process Air Systems
                     Nitrogen Gas Systems

        SUPPORT SYSTEMS

                CIP Systems
                Biowaste Kill Systems – Continuous
                Biowaste Kill Systems – Batch
                Autoclaves

        HVAC SYSTEMS AND CLEANROOMS

                HVAC Systems
                Cleanrooms - Aseptic
                Air Locks - Gowning

        LABORATORY EQUIPMENT

                Incubators
                CO2 Incubators
                Water Bath Incubators
                Ultra-Low Temperature Freezers
                Refrigerators
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) and SAT (Site Acceptance Test). Some activities of FAT and SAT can be integrated into IQ upon approval of
the validation committee. When the IQ report is approved, the system is ready for the execution of OQ.

IQ PROTOCOLS
        PROCESS EQUIPMENT AND SYSTEMS
                Media Preparation and Hold Tanks
                Buffer Preparation and Hold Tanks
                Process Tanks
                Reactors – Organic Synthesis
                Bioreactors
                Evaporator Systems
                Distillation Tower Systems

        CLEAN UTILITY SYSTEMS

                USP Purified Water Storage and Distribution Systems
                WFI Storage and Distribution Systems
                Clean Steam Generation and Distribution Systems 
                Process Air Systems
                     Nitrogen Gas Systems

        SUPPORT SYSTEMS

                CIP Systems
                Biowaste Kill Systems – Continuous
                Biowaste Kill Systems – Batch
                Autoclaves

        HVAC SYSTEMS AND CLEANROOMS

                HVAC Systems
                Cleanrooms - Aseptic
                Air Locks - Gowning

        LABORATORY EQUIPMENT

                Incubators
                CO2 Incubators
                Water Bath Incubators
                Ultra-Low Temperature Freezers
                Refrigerators
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 is performed and the verification data are 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 test through FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).
Some activities of FAT and SAT can be integrated into OQ upon approval of the validation committee. When the
OQ report is approved, the system is ready for the execution of PQ.

OQ PROTOCOLS
        PROCESS EQUIPMENT AND SYSTEMS
                Media Preparation and Hold Tanks
                Buffer Preparation and Hold Tanks
                Process Tanks
                Reactors – Organic Synthesis
                Bioreactors
                Evaporator Systems
                Distillation Tower Systems

        CLEAN UTILITY SYSTEMS

                USP Purified Water Storage and Distribution Systems
                WFI Storage and Distribution Systems
                Clean Steam Generation and Distribution Systems 
                Process Air Systems
                     Nitrogen Gas Systems

        SUPPORT SYSTEMS

                CIP Systems
                Biowaste Kill Systems – Continuous
                Biowaste Kill Systems – Batch
                Autoclaves

        HVAC SYSTEMS AND CLEANROOMS

                HVAC Systems
                Cleanrooms - Aseptic
                Air Locks - Gowning

        LABORATORY EQUIPMENT

                Incubators
                CO2 Incubators
                Water Bath Incubators
                Ultra-Low Temperature Freezers
                Refrigerators
PQ (Performance Qualification)
PURPOSE
PQ is to verify that the system performance satisfies all performance requirements including those specified in the
URS (User Requirement Specification). The performance requirements and acceptance criteria are defined in the PQ
protocols 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 actual production conditions, and 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.

PQ PROTOCOLS
        CLEAN UTILITY SYSTEMS
                USP Purified Water Storage and Distribution Systems
                WFI Storage and Distribution Systems
                Clean Steam Generation and Distribution Systems

        SUPPORT SYSTEMS

                Autoclaves

        HVAC SYSTEMS AND CLEANROOMS

                HVAC Systems
                Cleanrooms - Aseptic
                Air Locks - Gowning