ABSTRACT
Supplying the highly regulated biopharmaceutical
industry with equipment and services generally means
that vendors must adopt similar quality standards perti-
nent to the processes of the biopharmaceutical industry
applied to the vendor processes. These standards start
with the qualification of the equipment during the
development phase, the validation of the production
process, in-process controls and documentation during
the production process, release criteria, specifications and
tolerance settings and complete traceability of the fina-
lized product and product components. Once the
equipment is ordered or supplied to the end user, most
commonly the vendor will submit qualification docu-
mentation, support qualification, and acceptance testing
and in some instances, offer product or process related
validation services (1). The vendor’s production
processes often mirror the production processes of the
relevant industry the vendor supplies to. Additionally,
the vendors establish appropriate technical support
structures to be able to react rapidly to support needs of
the industry. This is of importance as the end user must
be able to answer to regulatory enquiries or when
equipment requires maintenance, calibration or repair.
Production interruptions cannot be tolerated as it might
result in multimillion dollar losses in revenue and put
drug product batches at risk.
