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U.S. Department of Health and Human Services

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Volume IV - 1.4 The Sample

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-01
VERSION NO.: 1.4

Section 1 - Laboratory Orientation

EFFECTIVE DATE: 10/01/2003 REVISED: 05/02/14

A sample, according to one dictionary, is a specimen, a part, or one of a number intended to show the kind and quality of the whole. Another dictionary says a sample is a part of anything presented for inspection or shown as evidence of the quality of the whole. We can draw from these definitions the essence of what a sample is to us.

 1.4.1 FDA Sample Requirements  

The FDA sample is a representative portion of a product that is to be analyzed to determine something about the quality of the batch or lot sampled. To make the sample representative, certain sampling procedures are used. Examples of these can be found in the Inspectors Operations Manual (IOM) or the pertinent compliance program.

The sample serves both as analytical raw material and as physical evidence in a court of law. We seldom know whether a sample will have to serve as legal evidence, so we make the assumption, from the beginning that it will. This means that the sample is treated with great care with respect to its identity, integrity and history.

Sample integrity is a most important concept that is to be thoroughly understood by all persons who handle samples, from the sample collector, through the sample custodian, to the physical science aide, to the analyst. When a sample is introduced into evidence, FDA establishes that it is the correct sample (identity) and that it has not been changed in any way prior to receipt by the analyst, and that it represents the state of the lot as originally sampled. To say "not to our knowledge" is not sufficient. Everyone in the chain of custody is able to prove the integrity of the sample, conclusively.

 1.4.2 Sample Accountability

Before the analyst analyzes an FDA sample, the training supervisor will instruct the analyst in the policies and procedures that are to be followed to preserve sample integrity and to show continuity of sample handling. Sample accountability calls for entries on the analytical worksheet and in the web application, such as FACTS or LIMS, to document who handled the sample and when and how sample integrity was maintained. The instructions are given in the Field Accomplishments and Compliance Tracking System (FACTS) guidelines, the Laboratory Information Management System (LIMS), or local Standard Operating Procedure (SOP) provided by the local web application trainer. Study the FACTS and LIMS documents and follow the prescribed procedures when handling samples.

 1.4.3 Reporting Sample Analysis

The analyst is responsible for an accurate and complete analysis of the sample and a written or electronic report of the analysis. All analytical data is to be recorded only on the FDA worksheet designed for the purpose [the Analyst Worksheet (FD-431), or modification of this form] and on supporting documents, such as instrument charts, which are attached to the worksheet – unless otherwise defined by an approved deviation in the laboratory’s Quality Management Plan. Approval of any deviations is to be obtained through the Office of Regulatory Science.

Before the analyst analyzes a sample, including samples collected solely for training purposes, the training supervisor will instruct the analyst on how to prepare a worksheet or start the process in LIMS. ORA Lab Manual, Volume II, sub-section on “Analyst Records”, describes the policy and gives instructions for preparing the worksheet.

 1.4.4 Field Accomplishments and Compliance Tracking System (FACTS) and Laboratory Information Management System (LIMS)

The Field Accomplishments and Compliance Tracking System (FACTS) was developed to centralize the data gathered by ORA into one nation-wide system. Therefore, FACTS is recognized as FDA’s automated system for field assignments, firm information, compliance actions, and time reporting. The Laboratory Information Management System (LIMS) is ORA’s national laboratory database used to manage sample testing. Using FACTS and LIMS will be an essential part of the analyst’s responsibility to report analytical information on all work products.

Basic FACTS and LIMS training will be provided by the local web application training unit during the training period.