Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 12
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212.5.2 Splitting and Transferring Samples between FDA/ORA
Laboratories or External (Non-ORA) Entities
If additional analysis of a sample will be performed at a facility other than the designated
servicing laboratory, an interlaboratory split/transfer is performed in FACTS or LIMS.
A sample that needs an additional analysis performed by a second FDA/ORA laboratory
or external entity (e.g. non ORA contract laboratory for specialized testing, return of a
claimant’s sample) may be split into smaller portions and shipped.
For samples that are split between FDA/ORA laboratories, each examining laboratory
handles and describes its portion of the sample as an original analysis. The original
servicing laboratory retains an intact 702(b) portion, when required. The receiving
laboratory is informed of the amount retained as the 702(b) portion.
2.5.2.1 Recording the Sample Transfer on the Analytical Worksheet
Documentation on the analyst worksheet includes the following:
•
description of sample and amount delivered,
•
how it was prepared for delivery,
•
how it was identified and sealed,
•
brief explanation as to why the sample was sent,
•
to whom the sample was sent and,
•
date of shipment.
2.5.2.2 Recording Sample Transfer through FACTS or LIMS
The FACTS or LIMS “Sample Transfer” “Split” operation documents this operation. The
“Split” will add a unique alphanumeric identification after the sample number for each
sample portion that is split or transferred within the laboratory.
The FACTS or LIMS “Sample Transfer” “Split” operation documents sample splits.
This operation is performed by the original servicing laboratory and documents the
sample splitting between the original servicing laboratory and another ORA facility or an
external entity.
2.6 Reserve Samples
At the conclusion of the analysis, the analyst annotates the status of the reserve sample on
the worksheet and prepares the reserve sample for storage or shipment.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 12 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
http://
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