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 effectiveness.

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 support.

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 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 management.

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.

URS – DQ – VP – VRA – IQ – OQ – PQ

Simple to use and highly cost effective when used .


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Alex Kennedy
Validation Online