From Wikipedia,
the free encyclopedia
Webster's defines "valid" as
having a conclusion correctly
derived from premises and lists
several synonyms for the word:
sound, cogent, and telling.
Synonyms of "validate" include to
verify, substantiate, and confirm.
The basic philosophy of validation
follows directly from its
definition. Validation is the tool
with which we provide documented
evidence that the facilities we
build, the equipment we operate,
and the standard operating
procedures (SOPs) and
manufacturing formulae we follow
will consistently produce products
that meet their predetermined
specifications and quality
attributes.
The underlying justification
for performing validation is that
"quality cannot be tested into a
product". Rather, quality is the
end product of a thoroughly
understood, properly designed,
implemented, and controlled
manufacturing process. And, like
the manufacturing process itself,
a validation program that is not
properly designed, implemented,
and controlled will be difficult
to manage and may not produce the
desired level of product quality
assurance (QA).
Validation is a corporate
responsibility, and, as such, it
is of little significance which
department oversees the validation
effort. There may in fact be
separate groups to validate
different parts of the
manufacturing process, production
equipment, etc. The task of
validation may be divided up among
process development, engineering,
technical services, quality
control (QC), and validation
groups as appropriate, or it may
be handled by a single group,
depending on the size of the
corporation, number of systems
involved, and the breadth of its
product lines. Ultimately, the
validation test plan or protocol
must be reviewed and approved
prior to initiating testing by all
departments that will be
participating in the validation
effort, including any support
groups that may be required to
provide technical assistance.
In the planning phase prior to
validation, each department on the
validation team should be
consulted for input toward
defining the scope of the project
and test requirements and to
commit their resources to the
project During the review and
approval process for validation
documents, each department
representative should assure that
the technical con tent is accurate
and that upon completion of the
proposed testing, corporate
quality, manufacturing, and
regulatory requirements will be
met During review of the final
validation acceptance report
following testing, each department
representative should verify that
the document is accurate and
complete and that the objectives
of the validation protocol were
indeed met.
