During the validation process, changes may be
required. Change control is the procedure to
provide documented evidence of any change
that has been performed. Once it is determined
that a change is required, the change is documented and implemented. After implementation of the change, the changed process must be
revalidated. Revalidation starts at the beginning
and continues through the entire validation life
cycle of the process, reviewing the effects of the
change on the previously documented IQ, OQ,
and PQ results.
Example of OQ checklist.
that all equipment, control loops, and devices
are installed and functioning as specified. This
includes any computerized hardware and software that control the installed equipment. The
steps of IQ include ensuring that the equipment
complies with the design specifications and a certificate of conformance accompanies the equipment or components of the systems.
The IQ documentation consists of a series of
verification checklists and forms, P & ID drawings,
electrical schematics, and equipment manuals.
An audit of the installed system is performed
to confirm that the system installed meets the
Operation qualification (OQ)
The operation qualification (OQ) documents that
each piece of equipment and its control system
used in the process is performing within specified parameters. The OQ starts after the installed
system has been thoroughly audited and deemed
operational. Completion of the OQ ensures that
all the installed equipment and processes operate
as designed. It proves that all the alert and action
limits and system tracking mechanisms that have
been designed into the system by the manufacturer are in place and functioning as specified.
Performance qualification (PQ)
The performance qualification (PQ) starts as
the system begins commercial operation. The
PQ documents that the entire system can operate consistently and will produce a product
meeting the predetermined specifications of
the facility. Even though it has been established
that all components of the system have been
installed according to the installation specifications, and that they operate according to the
specifications of the manufacturers, it is still
uncertain that the system is robust and will
function consistently over time.
Performance qualification puts the entire
cycle of the process together to validate that it
produces consistently according to specifications. The PQ also ensures that the equipment
and personnel are adequately monitoring, sampling, and testing the product and process.
Additionally, performance qualification contains the disaster prevention/response/recovery
plan. It ensures that mechanisms are established
to trigger an action when an alert limit has been
reached. Also, PQ documents action steps taken
in the case of a facility failure or shutdown due
to mechanisms beyond the control of the system,
such as a tornado, hurricane, or earthquake.
The summary report
Once all the documentation is accumulated
from the installation qualification, operation
qualification, and performance qualification, a
summary report is prepared. This completes the
validation Master Plan. It consists of a summation of the life cycle that has been outlined in
the validation protocol, documentation of the
testing, and verification of the test data. Once
data is compiled and verified, statistical analysis
is performed on the data and included in the
The concluded validation process is a documented and verified record of the installation,
operation, and performance of a manufacturing system, which was defined in the validation
Master Plan. The execution of the validation
process defines the normal operating functions, provides documented procedures to
evaluate the system, and allows preventive and
corrective actions to be executed in worst case
scenarios. The facility staff is able to operate,
monitor, and evaluate the validated system.
The summary report becomes the reference
that defines the operational and performance
characteristics of the system that can be
referred to when questions arise or changes to
the system are proposed.
Jan Eudy is a technical resource for ESD,
cleanroom, food, and healthcare garments and
products. At Cintas, she directs the quality system
and ISO registration for cleanrooms and supports
validation and sterile services. She is President
Emeritus and Fellow, Institute of Environmental
Sciences and Technology.