Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 3
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212.1.2 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)
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 3 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
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