2.

Guideline — Design Qualification

Design qualification is documented evidence
that quality is built into the design of facilities
and operations.
Policy: the company must prepare or adopt
appropriate guidelines for design qualification
(DQ), installation qualification (IQ),
operational qualification (OQ), and
performance qualification (PQ).
2.1 Background
The standard of any facility of operation is
highly dependent upon the quality of the
design and, therefore, the staff employed to
undertake the work. A design qualification
protocol, or report document, should detail
and record the disciplined, structured
approach followed. This will provide a useful
lead into the installation qualification (IQ)
stage.
2.2. Typical document
The principal information included should be
as follows:
_ HAZOPs (hazard and operability studies)
_ Modular design, with drawings and
specifications produced
_ Zone classification studies, etc.
Confirmation of the structured and rigorous
approach to design, including comments on
confirmation of design standards adopted
referring to:
_ Key issues underwritten by QA
_ Company standards
_ Confirmation of the use of appropriately
qualified staff
_ Confirmation of the attention paid to GMP
issues (e.g., by GMP audits)
_ Key reference texts on cGMP issues
_ National and international codes
_ Confirmation that available technology
transfer information has been used
_ Confirmation that change control systems
have operated effectively
2.3 Design qualification report
Policy: upon completion of each stage (DQ, IQ,
OQ, PQ), a document review or report
detailing results compared against the
requirement and recommendations for future
work must be prepared and accepted by
appropriate management before
proceeding to the next stage of validation or
implementing the process.
3. Guideline — Installation Qualification
This qualification is a documented
demonstration that facilities and operations
are installed as designed and specified and
are correctly interfaced with systems.
3.1 Installation qualification protocol
The IQ protocol should include a statement of
the data required and acceptance criteria to
be met for installation of the system or
equipment to verify that the specification has
been satisfied.
The protocol should include as applicable, but
not be limited to:
_ Engineering drawing and documents
_ Building finishes
_ Process and utilities (services) flow diagrams
_ Piping and instrumentation diagrams
_ Equipment and instrument specifications
_ Manufacturers’ drawing, equipment
maintenance, and operating manuals
_ Spare lists
_ Maintenance schedules
The IQ protocol should also ensure that
equipment and instrumentation is clearly
described and suitably labeled as to vendor,
model, capacity, materials, and other critical
criteria.
The IQ protocol should ensure that
instrumentation has been calibrated
according to approved procedures and that
the measurements are traceable to defined
national or international standards. All such
calibrations and detailed control parameters
must be recorded and records securely kept.
It should also ensure that change control
systems are in operation, and that all
systems have been verified to operate under
no load conditions.
3.2 Installation qualification report
_ Results as compared against the protocols
_ Recommendations for future work
_ Must be prepared and accepted by
appropriate management, as defined under
3.6 (responsibility), before proceeding to the
next stage of validation or implementing the
process
4. Guideline — Operational Qualification
The operational qualification provides a
documented demonstration that facilities
an operation’s function as specified.
4.1 Operational qualification (OQ)
protocol
The OQ protocol should:
_ Include a complete description of the
purpose, methodology, and acceptance
criteria for the operational tests to be
performed
_ Ensure that instrumentation is in current
calibration
_ Ensure that detailed control parameters
have been established and recorded for each
instrument loop
_ Ensure change control systems are in
operation
_ Ensure that standard operating and
maintenance procedures have been
developed (drafted) for each system, to
ensure continued operation under defined
conditions
_ Ensure that training modules and training
sessions for production, engineering, and
support personnel have been developed,
conducted, and documented during this stage
Where appropriate and documented in the
validation master plan, the IQ and OQ
protocols may form a single document which
clearly defines the acceptance for each
test(s).
4.2 Operational qualification report
_ Results as compared against the protocols
_ Recommendations for future work
5. Guideline — Performance Qualification
The performance qualification is a
documented program to demonstrate that an
operation, when carried out within defined
parameters, will consistently perform its
intended function to meet predetermined
acceptance criteria.
Operation, maintenance and calibration
procedures: Before commencing
performance qualification, authorized
procedures must be in place for routine use of
the facility or operation, training of operators,
routine calibration and maintenance,
notification and recording of problems, and for
the definition of actions to be taken in the
event of breakdown. 5.1 Performance
qualification (PQ) protocol
The PQ protocol should:
_ Include a complete description of the
purpose, methodology, and acceptance
criteria for the performance tests to be
performed
_ Ensure that change control systems are in
operation
_ Ensure that any outstanding actions
(exceptions) from IQ or OQ are recorded and
recommendations for remedial actions are
justified and approved
_ Ensure that maintenance and calibration
routines are in operation
_ Ensure that all SOPs have been finalized and
approved at this stage
_ Ensure that operating staff have been
trained according to the approved SOPs
_ Ensure that performance qualification
testing has been carried out using the same
personnel who will routinely operate the
system or equipment
_ Ensure that all deviations from the
validation protocol are investigated and
documented
_ Ensure that sufficient lots or samples will be
evaluated to demonstrate adequate process
control
_ Ensure that, before approval is given to
allow PQ testing to proceed, all IQ and OQ
results are reviewed and accepted
5.2 Performance qualification (PQ)
report
_ Results as compared against the protocols
_ Recommendations for future work
_ Must be prepared and accepted by
appropriate management before proceeding
to the next stage of validation or
implementing the process