Lean Times Have
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
The majority of my time was
Dispelling incorrect interpretations of the requirements.
Explaining away hearsay.
Introducing accountability and culpability.
Introducing cost effectiveness methods.
So where can this cost
effectiveness come from? Quite
simply it comes from the proper use of the three top level validation documents;
Requirements Specification (URS), Design Specification (DS) and the Design
The URS, has detailed the actual
needs of the end user, in functionality, training, documentation, engineering
drawings and support.
The DS, is a detailed design put
forward (either from an in-house resource or from a vendor) which will satisfy
all the requirements detailed in the URS.
The DQ, must verify that the DS
will in fact satisfy the URS.
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 approved document).
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 validation methodology.
DQ – VP – VRA – IQ – OQ – PQ
Simple to use and highly cost effective when used.