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U.S. Department of Health and Human Services

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Volume III - 3.8 Definitions

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-03

VERSION NO.:2.0

Section 3 – Recording of Results – Analyst Worksheet

EFFECTIVE DATE:
03-25-04
REVISED: 05-02-14

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, photocopies 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 Shipping and Collection Problems) – The sample is rendered unusable for analysis due to shipping of collection reasons, such as broken containers, improper collection, sample not collected. For other reasons, such as PAC codes, incorrect servicing laboratory, laboratory problems, the information is corrected in FACTS or LIMS the sample is properly transferred to another servicing laboratory in FACTS or LIMS.

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:

  1. 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).
  2. Samples collected to gather authentic data (e.g. food standards).
  3. 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).