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| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-03 | VERSION NO.:1.5 | Section 3 – Recording of Results – Analyst Worksheet | EFFECTIVE DATE: 03/25/2004 | REVISED: 08/11/2008 |
3.8 Definitions
Analytical Package - A collection of printed records designed to provide
a complete account of laboratory's analytical efforts and related findings
and conclusions.
Attachments (to an Analytical Package) - Broken seals, instrument generated
charts, chromatograms and spectra, contractor provided data, computer printouts,
standard curves, photographs, x-rays, exhibits are to support laboratory findings
and conclusions.
Claimant's Portion - This is the portion of a sample, normally referred
to as a 702(b) sample, that is retained by the laboratory in its original condition
for examination by any person named on the label of the article, or the owner
thereof, or their attorney or agent per the requirements of Section 702(b) of
the FD&C Act and 21 CFR 2.10.
Labels or Labeling - Labels or labeling is commercially printed material
that describes the contents of a sample package and is found in association with
the product. Labels or labeling include carton labeling, bottle labels, all inserts,
product packaging, promotional materials, photographs or photocopies of original
label, or verified handwritten copies. Labels or labeling is often referred to
as Outer Container Labeling, Immediate Container Labeling, and Package Insert.
Labels or labeling is comprehensively defined in the FD&C Act, Sections 201(k)
and 201(m).
Sample Classifications - Samples are assigned by laboratory supervisors
to classes based upon whether they are considered "regulatory (classes
1, 2, 3, & 5)" or "non-regulatory (class 4)" in nature,
and the results of the laboratory's examination.
- Class #1 (In Compliance) - The sample meets established standards
(CFR, USP, etc.) or policy guides in the absence of standards.
- Class #2 (Regulatory Action Not Indicated) - The sample:
- fails to meet established standards, but does meet policy
guides;
- in the absence of standard guides, the results are not applicable
for regulatory actions because of the level or significance of these
results;
- the sample results indicate the need for further investigatory, compliance,
and/or policy follow-up and the worksheet/analytical documentation will be
forwarded to the responsible FDA office(s) for review. For example, the laboratory
identified a color which was permitted as a dye and not as a "lake" and
the difference between the two forms could not be determined analytically.
- Class #3 (Adverse Findings) - The sample fails to meet established
standards and policy guides; or the results, in the absence of standards and
guides, are of a level or significance to support a recommendation for regulatory
action. This classification is also used for documentary samples, exhibits
or other types of samples which are being held without analysis for evidence
in regulatory proceedings.
- Class #4 (No Classification Needed) - The sample is not of the
type for classification because the type of examination or the reason for analysis,
makes classification meaningless. Examples include survey samples where one
sample consists of multiple products or where there is no documentation to
support regulatory action. These include "Total Diet Samples" and
samples examined for another regulatory agency that has responsibility for
classifying the sample, or samples used in research, collaborative studies
or petition validation projects.
- Class #5 (Sample Not Analyzed or Reviewed) - The sample was collected
for analytical purposes but the decision was made not to review, analyze, or
hold the sample for further action.
Regulatory Samples - All samples collected for regulatory analysis.
Samples received from cooperating agencies may be regulatory or for information
purposes only. They are to be handled the same as FDA samples. The following
samples may be exceptions:
- Survey samples for gathering information only. The design of
the survey may not permit regulatory action (e.g. no 702(b) portion, insufficient
units analyzed, multiple manufacturers under one sample number).
- Samples collected to gather authentic data (e.g. food standards).
- Samples designated as laboratory quality assurance samples.
Responsible Supervisor - The laboratory's branch or section level
supervisor with primary responsibility for the sample being examined.
Standard Method and FDA "Official" Method - A method that
is traceable to a recognized, validated method. FDA "Official" methods
are those in compendia specified in the Food, Drug, and Cosmetic Act and prescribed
in the Code of Federal Regulations, 21 CFR 2.19. The compendia listing official
methods include "The United States Pharmacopeia/National Formulary", "The
Homeopathic Pharmacopeia", "Official Methods of Analysis of the
AOAC", and "Food Chemicals Codex". Official methods of analysis
may also be found in FDA published analytical manuals for each compliance program
category. Official methods of analysis may also be found in FDA published analytical
manuals to include the Pesticide Analytical Manual (PAM) and the Bacteriological
Analytical Manual (BAM).
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