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Volume III - 2.1 Introduction

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.9

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04-17-2004REVISED: 05-02-14

The FDA national procedures for sample management are found in ORA Laboratory Manual, Volume II, ORA.LAB.5.8 Sample Management. This document provides additional sample chain of custody work instructions for such operations as laboratory receipt of sample, storage, protection, opening the sample package, handling split samples, shipment of samples, and disposition.

Field Accomplishments Compliance Tracking System (FACTS) centralizes the data gathered by Office of Regulatory Affairs (ORA) into one nation-wide system. FACTS is therefore recognized as the Food and Drug Administration’s (FDA) 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 reporting analytical information on all work products.

Basic FACTS and LIMS training is provided by local web application training unit during the analysts training period.

 2.1.1 Sample Documentation

Laboratory receipt of samples is documented in FACTS or LIMS. The method of documenting the laboratory receipt of samples is dependent on the following:

  • sample has been entered into FACTS or LIMS for sample analysis prior to arriving at the laboratory;
  • sample has not been entered into FACTS or LIMS for sample analysis prior to arriving at the laboratory, or
  • sample has been entered into FACTS or LIMS for storage only.

If a sample has not been entered into the FACTS or LIMS application prior to arriving at the laboratory, the sample accountability procedures can not be performed (e.g. laboratory receipt, sample transfer). Sample analysis can proceed only with management approval and special circumstances (e.g. when the nature of the sample dictates that withholding such analysis will seriously affect the product causing microbial growth, deterioration or contamination, or immediate results are needed due to an emergency situation).

 2.1.2 Definitions

Analyst - The term "Analyst" applies to all professional and paraprofessional positions associated with the analytical operation of the laboratory.

Analytical package - The Analytical package consists of the Analytical Worksheet and other documents directly related to the sample (e.g. collection report, memorandum of analysis).

Controlled areas - Controlled areas are designated areas that contain information or material requiring additional protective measures and strict access controls. These areas may store pharmaceuticals, alcohol, samples, or be a document/computer room. Authorized personnel are allowed only in controlled areas.

Controlled drugs and substances (Schedule I and II) - Controlled drugs and substances (scheduled I and II) are designated by the Controlled Substance Act as amended to 21 Code of Federal Regulations (CFR) 1308.11-12, April 2003.

FACTS - FACTS is the FDA acronym for the Field Accomplishments and Compliance Tracking System.

Laboratory supervision - Laboratory supervision includes managerial positions from the First-Line Supervisor to the Laboratory Director.

LIMS – LIMS is the FDA acronym for the Laboratory Information Management System.

Official Sample (21 CFR 2.10) - An official sample is one taken from a lot for which Federal jurisdiction has been established. If violative, the official sample provides a basis for an administrative or legal action. Official samples generally consist of "goods," or a physical portion of the lot sampled, but not always. Official samples are further classified according to the manner in which they are collected, how Federal jurisdiction is established, and their intended use or purpose.

Sample accountability - The term "sample accountability" includes requirements for proof of sample receipt, storage, transfer of sample or sample portions between individuals, analysis, disposition authorization and destruction. Records covering these transactions are part of the regulatory file. A permanent FACTS or LIMS record achieves uniform accountability for samples in the FDA/ORA laboratory system. See ORA Laboratory Manual, Volume II, ORA.LAB.5.8 Sample Management.

Sample custodian – The Sample Custodian refers to person(s) granted the role of Sample Custodian within FACTS or LIMS. The Sample Custodian refers to the person(s) responsible for receiving all samples into the laboratory, both physically and electronically in FACTS or LIMS, from the collector and assures the samples are stored under the appropriate environmental conditions until such time as the sample is transferred to the analyst to whom it is assigned. The Sample Custodian also ensures proper disposition of all samples in FACTS or LIMS, whether or not the sample is analyzed.

Samples - Samples are identified as all items, both domestic and import, collected and identified as Official Samples. Import samples need not be sealed, unless District Policy dictates, as long as the integrity of the sample is maintained. (See Investigators Operations Manual, IOM Chapter 4, Official Samples and Section 2.10 References)

  • 702(b) Portion. - In accordance with the provisions of Section 702(b) of the FD&C Act, a portion of an official domestic sample collected directly from the manufacturer or if requested under other circumstances, is to be available for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent. The two exceptions to this regulation are Medical Devices and Import Samples. Medical devices are not specifically referenced in 21 CFR 2.10(b) and samples being imported or offered for entry into the United States are exempt under 21 CFR 2.10(b)(4).

The sample, no matter what the content, may be involved in a court proceeding, and therefore must be preserved by the best means possible. Preservation must be effective until any legal or regulatory proceedings are terminated.