This overview is a stepwise guide
intended to help customers to understand the commitment
to quality afforded every sample that enters our laboratory
system. It isn’t an exhaustive procedural document,
but rather a synopsis of the QA program and its benefits
to our customers.
The cornerstone of the quality program at Metabolic
Solutions is the training and expertise of the staff.
Our team of laboratory professionals has over 100
years of analytical experience that is applied to
the operation of our facility every day. Metabolic
Solutions on going commitment to quality is demonstrated
by our FDA approved cGMP training program. We continually
strive to provide the best quality data in a timely
and cost-effective manner.
Upon receipt of any analytical samples, laboratory
personnel will inspect and log those samples into
our central computer system. Any problems or discrepancies
with the samples will be immediately documented and
the customer contacted. All shipments are assigned
a unique number ("job number") and each
sample within that shipment a unique "sample
number". All pertinent information concerning
that sample such as client name, sample name, collection
date and time point are entered and permanently associated
with the "sample number".
Batch sheets are generated from the login procedure
and verified versus the actual samples by laboratory
personnel. All analytical procedures are carried out
using written, current and approved standard operating
procedures. Every reagent used is recorded with respect
to its name, manufacturer and lot number. The samples
are prepared, derivatized and loaded onto the analytical
instrumentation using the unique sample number as
an identifier. Prior to the analysis of any samples,
the GC/MS is qualified by means of a standard auto
tune and by injection of a series of appropriate blanks
and standards. The first material injected is a blank
sample. This blank contains all reagents and solvents
but is devoid of sample. This blank analysis assures
that no interfering substances are present in the
reagents, solvents or analytical systems.
These standards (labeled and unlabeled) reflect the
concentration and isotopic composition expected of
the samples to be analyzed. They are examined with
regard to proper chromatography, mass spectral response
(sensitivity) and integration parameters. A pure,
unlabeled standard and background plasma sample are
injected and compared versus theoretical isotopic
calculation to further ensure proper MS operation
and tuning. Once the analyst is satisfied that the
GC/MS is operating properly, a standard curve is prepared
covering the expected isotopic or concentration range
of the samples to be analyzed. After running the standard
curve several times, a slope and y-intercept are determined
using standard linear regression techniques in a spreadsheet
program (i.e., Excel).
Samples are prepared in the same way as standards.
The standard curve is analyzed with every run of samples.
Blanks are run before and after each analytical run.
The analyst to ensure proper method selection, sample
selection, chromatography, peak selection and integration
examines every sample print out. Each approved print
out is signed and dated by the analyst. Any problems
encountered by the analyst require re-injection or
retesting of the original sample. All data, original
and retested, is kept with the data package for review.
When the analyst is satisfied, the data is entered
into a spreadsheet software program (i.e., Excel)
and the appropriate calculations, as specified in
the individual methods, are applied. The raw data,
final data and calculations are forwarded along with
the original investigator paperwork and receiving
documents to the Director of Quality Assurance for
final review.
Each step of the process, including every individual
sample analyzed, is then reviewed and verified by
QA and the final documents, once approved, are signed
and dated by the Director. The final data is copied
(and those copies archived at Metabolic Solutions
under the unique job number) and the original reports
are forwarded to the investigator for review. |
