Ensuring Digital Data Integrity
The computer-driven system should be able to generate audit trail
reports and provide detailed, time-stamped information about each
step in the electronic records process.
By Ricki Hartwell, Thermo Fisher Scientific
The effectiveness of pharmaceuticals depends on their ability to properly dissolve in the fluids of the gastrointestinal tract prior to the absorption of the drug’s active
ingredients in the patient’s bloodstream.
The bioavailability of the pharmaceutical
essentially determines the extent of the drug’s
therapeutic benefit. Substandard bioavailability
could limit the effectiveness of the treatment and
potentially put the patient in danger.
Dissolution testing is routinely undertaken during
drug development to provide critical information
about the drug release, to ensure batch-to-batch
consistency and to predict the drug release profile.
The dissolution rate of an oral dosage form
largely depends on the quality and purity of the raw
materials that have been used in its production, as
these essentially determine whether the drug is able
to travel within the body and break down its active
ingredients at the appropriate time.
Water is one of the most important components
used in the processing, formulation, and
manufacture of pharmaceutical products and
its purity will impact the dissolution profile
and, subsequently, the bioavailability of the
drug. As such, to maintain adherence to global
microbiological quality standards, the purity of
pharmaceutical grade water must be monitored and
confirmed prior to its use.
Ion concentration, conductivity, dissolved oxygen,
temperature, and pH measurements of water are
all critical steps in the daily routine workflow
of pharmaceutical laboratories, allowing them
to ensure water is of the appropriate grade and
therefore suitable for its intended use.
Generating accurate, precise, and repeatable
critical water quality values should be a top
priority for pharmaceutical laboratories to ensure
pharmaceutical integrity. Drug development
facilities are required to take all necessary
measures to facilitate the production of highly
reliable quality control data.
This could include utilizing high performance
equipment and well trained personnel, as well as
ensuring best practices are maintained and adhered
to at all times. Part of this can involve compliance
with the stringent requirements of the U.S. Food
and Drug Administration (FDA) 21 CFR Part 11
regulation for electronic records and signatures.
Signatures are required as part of standard
protocols to ensure that various protocols, and
quality control measures, are undertaken correctly