There has been much discussion recently about validation costs.  How can we measure the costs and how can we (once we know them) control them.


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 correctly.


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 the project.


So to 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 using.

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 – P2Q


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.