5
Receipt and Storage of Materials
a) You will receive 1 or 2 courier shipment(s) containing practice samples and test samples.
The samples pack(s) will also include packaging labels and customs declaration
documents.
Because it is not certain how the transport documentation or sample labels
will be retained/added to/modified by Customs Officials (likely to vary from country to
country), it is preferred that you have a colleague, not directly involved in the study,
remove all documentation not required for the study. The samples will arrive double
bagged.
Please have a colleague carefully remove the outer bag (which is labeled
with customs declarations) and discard, and present to you just the inner sample
presentations that have the designated sample name labels
. Use only the designated
sample names for the study and reporting results.
Note:
Samples are intended for the use of this study only; and are not for human
consumption. You do not need to return the samples.
b) The shipment will also contain a receipt acknowledgement form for you to return,
indicating receipt and condition of the items shipped.
c) Samples are to be kept at room temperature until the start of analysis.
d) Samples are to be prepared and used on the same day. No storage of samples for next
day analysis is allowed.
e) All work should be completed within 30 days of receipt of the materials, unless other prior
arrangements are made. If this schedule cannot be met, the Study Director should be
notified as soon as possible.
System Suitability Checks
a) System suitability checks as outlined in the method should be analyzed as part of each
analytical run and should meet the outlined acceptance criteria.
Analysis of the Practice Samples
a) The practice samples should be prepared and analyzed with a freshly prepared 6 point
calibration curve.
b)
Once the practice samples have been successfully analysed, the results are reviewed
and cross checked please send via e-mail to the study director for review and approval.
Include all data, appendixes 3 and 4 and a copy of all chromatograms.
c) Once the practice sample results have been approved by the study director, the analyst
may proceed with the analysis of the actual test materials.
Analysis of Test Materials
a) The analysis of the test materials should be initiated immediately after the approval of a
successful analysis of the practice samples by the SD.
b) The test materials will consist of 20 randomly coded samples, a mix of powder and liquids
presentions. Refer to
Appendix 2
for a list of the test sample codes.
c) Each of the samples is to be prepared fresh singly and analysed once along with a single
preparation of each the practice samples. As the number of samples exceeds the
recommended number to be prepared in a single day, analysis will need to take place
over two days running 12 samples on day one,10 test samples and the two practice
samples and 10 samples on day two, 8 samples and two practice samples.
Vitamin A & E MLT Protocol
For ERP Use Only
DO NOT DISTRIBUTE
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