Validation vs. Qualifcation - Process vs.

Laboratory
N.W. Read, J.M. Read, D.J. Willis, Laboratory Management Systems, Inc., New Castle, DE and Edwin L. Crow, YATOKA Associates, Inc., Santa Fe, NM
Qualifcation (Equipment)
Assuring through inspection, testing and
documentation that:
The correct equipment has been installed
The equipment has been properly installed
The equipment performs according to pre-
established, written specifcations
Qualifcation applies to equipment.
Validation (Process or Method)
Accepted defnition from the FDA: establishing
documented evidence which provides a high
degree of assurance that a specifc process will
consistently produce a product meeting its pre-
determined specifcations and quality attributes.
Validation applies to processes or analytical
methods
Process vs. Laboratory Qualifcation
- Similarities and Differences
Both process areas and analytical laboratories
must use qualifed equipment (IQ/OQ).
Manufacturing areas must validate the
manufacturing process.
Analytical laboratories must validate the
analytical method.
Defnitions for the Qs
Design Qualifcation (DQ) provides a set of
user specifcations set forth to ensure that
the appropriate instrument is chosen for the
intended use.
Installation Qualifcation (IQ) verifes that the
specifed equipment was installed correctly.
Operational Qualifcation (OQ) verifes that
the equipment is operating according to
specifcations.
Both IQ and OQ are required for new equipment
or equipment that has been redesigned or
relocated.
Various terms have been used to describe periodic
Re-qualifcation (RQ) including Performance
Qualifcation (PQ), Performance Verifcation (PV) or
OQ. The term RQ avoids confusing re-qualifcation
with the PQ of validation. For most analytical
equipment, OQ and RQ can be tested using the
same procedure.
PQ is often referred to as Performance
Qualifcation in the process world; showing that
the equipment will perform as required, i.e.
temperature ranges, vacuum ranges, etc. This
is different from OQ and RQ which show the
equipment works as designed. PQ shows that
the equipment will performs as demanded by the
process.
Periodic Re-qualifcation (RQ) needs to be
performed often enough to show that the
equipment continues to satisfy its design
requirements. RQ is required by regulation, and in
most cases must be performed at least annually.
RQ also minimizes the number of investigations
caused by failed equipment.
Process equipment also requires a periodic
PQ/RQ to demonstrate continued and adequate
performance.
Analytical Method Validation
Validation of an analytical method must always be
performed on qualifed equipment to ensure that
the method will work with similar equipment.
Method validation provides assurance that the
method produces accurate results under a range
of conditions that includes using other equipment
that also satisfes the DQ specifcations.
PSPQ Controversy
PSPQ - Product Specifc Performance Qualifcation
involves testing with samples of product (possibly
of questionable purity).
PSPQ is practiced at a few companies.
Others qualify with a traceable standard, not a
product.
Qualifying equipment with product adds little, if
any, value.
Not using traceable standards places the
qualifcation at risk.
Some experts even suggest that system
suitability adequately qualifes equipment (not
acceptable).
RQ/OQ/PQ should be performed with NIST
traceable or otherwise certifed standards.
PSPQ vs. PQ is frequently debated by chemists
and engineers.
Potential Problems of PSPQ
If an instrument fails PSPQ:
- The instrument might be misbehaving.
- The product may not meet specifcations.
- An investigation is always required.
If the instrument is being used for multiple
products, one must decide which product to test
with.
Use DQ to Design RQ
RQ is ideally performed using a traceable
standard (NIST, if available) and testing to DQ
specifcations.
- User needs outlined in DQ
- Defne test(s) required for RQ.
- Or follow guideline SOPs
When to Validate and When to
Qualify
Analytical methods must be validated.
Processes must be validated.
Process Control Systems must be validated.
Data systems must be validated (the application
performs one or more processes).
All regulated equipment must be qualifed.
In Summary
For process areas IQ/OQ/PQ demonstrates that
the equipment is installed correctly, is functioning
to specifcations and meets the demands of the
process..
For laboratory equipment IQ/OQ/RQ demonstrates
that the equipment is installed correctly and is
functioning to specifcations.
Validation proves:
that a process produces a product that is
consistent with predetermined requirements
or that an analytical method is robust and
will perform as required using qualifed
equipment.
For more information contact D.J. Willis, Laboratory Management Systems, Inc., 551 Mews Drive, Suite J, New Castle DE 19720 (302-571-1812)