At times like these it is worth having a close look at your
validation activities, are they as lean as the current times, or are they as
obese as the past times?
In twenty years as a validation consultant in the
pharmaceutical industries, I have encountered many variations in standards, from
the very thorough, to the extremely casual, but the great majority of all them
scored very low, when it came to efficiency and or cost
So where can this cost effectiveness come from? Quite simply, it comes from the proper use of the
three top level validation documents; User Requirements Specification (URS), Validation Plan Or Master Plan (V(m)P), and the Design Qualification (DQ). Get these three correct and
the validation will be properly directed, scoped and managed.
The URS, has detailed the actual needs of the end user, in
functionality, training, documentation, engineering drawings and
The Design Specification (DS), is a detailed design put
forward (either from an in-house resource or from a vendor) which is purported
to satisfy all the end users requirements detailed in the URS.
The DQ, must verify that this DS, will in fact satisfy the
This is the level that all aspects of design, installation,
operation, maintenance, documentation, training, calibration, cleaning and
installation, are challenged at. The
satisfactory execution of the DQ confirms that this DS satisfies all applicable
requirements as detailed in the URS, cGMP and the Health and Safety regulations.
It also documents the fact that all supporting
requirements have been reviewed and the review has been approved by
At this stage the Validation Plan can be completed (it may
have started earlier, but cannot be completed until the DQ has become an
The VP scope can now be detailed and, responsibilities and
methodologies can be detailed. Having fully
detailed the support documentation (FAT, drawing, specifications, calibration
certification) in the URS, the IQ and OQ will flow quite easily.
The documentation dovetails together and actually presents
you with a simple (at each stage), logical, traceable and cost effective
URS – DQ – VP – VRA – IQ – OQ – PQ
Simple to use and highly cost
effective when used