In the pharmaceutical industry, the traceability of prescription drugs is increasingly vital to the integrity of pharmaceutical products. By provid- ing more end-to-end visibility into pharma supply
chains, companies can better trace serialized products from wholesalers to end customers, enhancing the reliability of supply deliveries while also
offering a way to detect counterfeit drugs and track
With greater recognition of the importance of
traceability, increased demand is being placed on
the pharma industry to improve the robustness
of traceability requirements. The Drug Supply
Chain Security Act will eventually require serialization and item-level traceability of prescription drugs, enabling supply-chain partners to
track product ownership to the manufacturer or
Beyond the pharmaceutical supply chain, nearly
every functional area within the pharmaceutical
facility is now beginning to emphasize traceability.
This includes cleaning validation studies and water
quality monitoring, where thorough traceability
requirements help ensure the accuracy, performance, and reliability of critical total organic carbon (TOC) measurements. The TOC instruments
used for these measurements have become a widespread best practice throughout the pharmaceutical
industry, providing a simple yet effective way to
ensure that processes are in control.
Measurement traceability, as applied to TOC
analyzers, refers to an unbroken chain of comparisons relating an instrument’s measurements to a
known standard. For industries that rely on TOC
measurements, calibration and verification are the
most commonly used methods to align an instrument with a traceable standard for determining precision and accuracy.
Measurement failures and Out-of-Specifications
Out-of-Specification (OOS) results refer to test
results that fall outside established specifications.
When an OOS result occurs, FDA regulations
require that an investigation be conducted to
determine the cause and that a written record of
the investigation be made, including conclusions
and follow-up. Whether a sample preparation or
an actual process issue, there is a limited amount
of time before costs begin to rise as the root cause
investigation is conducted.
Although an OOS may seem inconsequential,
it can lead to production delays and question the
validity of data. An OOS can also compound the
risks associated with instrument certification, the
standard that is used, or even the person who is
performing the work. Cases where data drift out
of tolerance can severely affect business. As such,
metrology groups are under pressure to quickly
resolve these situations and re-certify an analyzer
for further use.
Improved traceability can shorten the resolution of an OSS and details or reports supplied
by vendors to help quickly close out non-conformances are invaluable. In particular, a failure
analysis report (FAR) is an important tool in
For example, an OSS investigation would be
triggered if a pharmaceutical company reports a
TOC value exceeding their limit for a cleaning validation (CV) study. The company may troubleshoot
this measurement and investigate if the instrument
is flawed, the vial contaminated, or if the sample
does indeed have a higher organic concentration.
If the components of the measure are supplied by
a single vendor, the vendor provides a FAR, which
cross references the lot numbers of the company’s:
Increased demand for pharmaceutical TOC measurement applications.
GE Water & Process
The Value of Traceability
standards are certified for
Image: GE Water & Process