| A number of high-profile drug failures and escalating costs
have led to increased scrutiny of the pharmaceutical industry
in recent years. While drug manufacturing has always faced
intense regulation, the push for quality and efficiency is moving
upstream. Driven by PAT, CAPA and other initiatives, companies
are striving to build greater quality into drug discovery and
development processes.
Liquid handling devices are among the most frequently-used
instruments in pharmaceutical laboratories and play an important
role in data accuracy. For these reasons, device verification and
calibration are essential cornerstones of laboratory quality assurance
programs. However, liquid handling technology is
advancing rapidly, becoming increasingly automated
and adapted for the handling of smaller volumes. This
is producing several effects. Firstly, regulations are not
keeping pace with new technology, leading to a lack of
relevant calibration standards or guidelines. In addition,
laboratories need to update their calibration procedures
to measure and document micro- and nanolitre
volumes quickly and accurately. |
