COST EFFECTIVE VALIDATION PART IV.
There has been much discussion
recently about validation costs.
How can we measure the costs and how can we (once we know them) control
It has been obvious for many
years now, that validation tasks that are not planned, managed and controlled
properly, have the potential to become out of control nightmares. The individual stages in validation are
of paramount importance in determining that each validation stage is sequenced
When these sequenced steps are
progressed through then each stage is properly scoped and documented. For instance it is quite the normal (but
very wrong) to find a protocol authors discussing product contact materials and
suitability of lubricants.
All such problems must be
reconciled at the design stage and the design should be validated by the
execution of the design qualification (DQ).
Then it becomes apparent that the
protocol author should only be authoring inspections and tests that verify that
what is designed is what is built.
When this strict layered approach
is enshrined in a company’s practices and procedures and put into everyday
practice then the addition of good quality templated documents renders the
validation process consistently reproducible.
At this stage, you start to
experience smother and more trouble free execution of projects and tasks as the
structured method precludes many problems from manifestation at a later stage in
sum it up:
You must set out your practices and procedure concisely –
in a formal approved document that all the required staff are trained in
You should use good quality templated bespoke protocols to
preclude the continual authoring of multitudes of protocol variations, following
the sequence below.
URS – VP – DQ – VRA – IQ – OQ – P1Q –
When you put this system into
regular use, you find after a period of settling down that this extra layer of
discipline, actually starts to deliver projects and tasks through to the
completion stage consistently on time.
It just takes certain amount of discipline to put the procedures in place
and manage them. Then it becomes a
whole lot easier for everyone.