responsible for validating the system. The site
management team may either write their own
protocols and perform their own testing, or
they may contract with qualified outside validation firms to perform these services for them. If
an outside firm is contracted to perform these
services, the facility using that system is still
responsible for assigning personnel to review and
approve the protocols. Further, the facility is still
responsible for executing the test procedures and
the validation processes while assuring the protocols were designed to validate what is actually
performed at their facility, under their control.
Employees who perform the validation have
ownership of the equipment and the process.
tion protocol is written. The validation protocol
consists of the design validation, a specific set
of test procedures and their acceptance criteria
for each of the systems being validated, and
for the specifications that are required over the
whole project. Once the validation Master Plan
has been prepared, and during the preparation
of the validation protocol, an assignment of
responsible parties is determined.
• The installation qualification is defined.
These are specifications that must be
achieved during the installation phase of
• The operation qualification is defined. These
are all the operation specifications that
must be met in order to assure that everything is going to operate as planned.
• The performance qualification specifications
are prepared. This is taking all the information derived from the installation qualification and operation qualification and
assuring that all the systems consistently
perform as specified.
• Change control is defined. These are
the steps to be taken if any changes are
required during the validation process.
In all of these phases, SOPs are prepared and
serve as the blueprint to perform each of the
qualifications. These SOPs are contained in each
of the phase method sections. A change control
process is used, if any part of these results fail
to meet the required specifications, to make a
change to either the specification or the system.
The change control is also outlined in the SOP
in the corrective action section.
What does validation involve?
Validation is a multi-disciplined process consisting of the installation qualification, operation
qualification, performance qualification, and
change control. The entire process is mapped in
the Master Plan.
The Master Plan
The project, or the overview of the validation
process, is the Master Plan for the validation
Once there is an overview, then the valida-
Example of Master Plan flow chart.
Work the validation Master Plan!
There are several components of the validation
Master Plan, and it is imperative that the Master
Plan be written before executing the validation
process. Otherwise, the validation can be partially completed, and bits of information that
are important can be lost. A validation Master
Plan consists of all the steps involved in the
entire life cycle of the validation. It will also designate responsibility and authority and who is
authorized to approve changes in the process of
validating the cleanroom. It will define the project purpose, scope, and definitions so that all
the individuals working on the validation team
are proceeding with the same directions, talking
about the same pieces of equipment, and working on the same process.
Also defined in the Master Plan are specifications that are to be distributed to vendors
and the documentation required to prove the
systems and equipment meet the end-use specified requirements. The SOPs, in their entirety,
become part of the Master Plan. These SOPs
may become a separate volume that will be used
on a continuing basis after the validation has
been completed to prevent deviations from the
Within the Master Plan protocol is the full
life cycle including schedules, deliverables, due
dates, and responsibility and authority designations. A vendor audit protocol should be part of
the validation process in the design specification
portion of the Master Plan. The SOPs should be
very specific to the system and equipment being
used because they will become the method of
determining how the system should be monitored once it is in place. The SOPs should be
written clearly and concisely so they can be
understood by everyone involved in validating
Vendors are required to provide a complete
documentation package including certificates
of conformance on any of the specifications
that are required. Prior to the start of specific
validation testing, the necessary calibrations