INSTRUMENT VALIDATION FOR REGULATED STUDIES - Flow Cytometry in Drug Discovery and Development - page 267

If one wishes to take full advantage of the nuances of GLP and GCP requirements
and the roles and responsibilities of the staff concerned, a productive partnership
between the laboratory and an experienced quality assurance unit cannot be under-
emphasized because guidance is sometimes less clear for GCPs. For example, an
important core feature of both GLPs and GCPs is the establishment of predicate
processes that identify and define requirements for instrument validation. Although it
is quite clear that management holds the approval role with the quality assurance unit
exerting an independent oversight function for GLP studies, it is not, in fact, specified
who approves release for GCP efforts. Moreover, a simple memo can suffice in a GCP
study in places where one would defer to more regimented analytical procedures and
standard operating practices for GLP studies. So, while the work breakdown pre-
sented in Figure 13.2 is quite useful for those engaged in GCP studies, variance in the
level of detail, method of documentation, and assignment of responsibilities can
be introduced as a function of the biopharmaceutical concern hosting the studies. For
instances where the same staff might be involved in both GLP and GCP efforts, it is
often more efficient and safer to extend the GLP work stream to the GCP efforts to
simplify processes for all involved.
13.3 HYBRID SOLUTIONS
From one perspective, it could be stated that every instrument/system validation
problem is met with a hybrid solution because of the need to stitch a variety of
elements together to ultimately represent a coherent and infallible process to
guarantee data authenticity. In practice, the terminology of a hybrid solution is used
primarily to identify areas where one supplements the validation with information or
assurances provided by the vendor and/or the mosaic of technical and procedural
controls that might be used to reach the end goal of instrument/system validation. One
must take note, however, of the liabilities associated with hybrid approaches
inasmuch as, for example, reliance on a vendor for IQ/OQ of a flow cytometer
cascades to the correlated need to qualify the vendor. That is, as the vendor holds no
responsibility toward your system, outsourcing the IQ/OQ in this way incurs the
additional activity of vendor qualification. The phrase of caution sometimes bantered
about in the field that “validation means validation” seems to hold special importance
for those who approach their validation exercises with an excessive reliance on hybrid
solutions, so the watchword is to proceed with caution in this space.
13.4 FEEDING AND CARE OF YOUR VALIDATED SYSTEM:
CHANGE CONTROL
The milestone of instrument/system validation is a significant accomplishment that
enables flow cytometry laboratories to fully engage in regulated studies. Lack of
appropriate change control processes can void these efforts almost instantly, so the
care taken for a planned installation, including appropriately documented IQ/OQwith