ASTM E899-82 (1987)

Guide for Records Management in Mass Spectrometry Laboratories Performing Analysis in Support of Nonclinical Laboratory Studies (Withdrawn 1992)

General Information

• Status: Withdrawn
• Withdrawal Date: 14-Aug-1992
• Technical Committee: D02 - Petroleum Products, Liquid Fuels, and Lubricants
• Drafting Committee: D02.04.0M - Mass Spectrometry

Standards Content (Sample)

ASTM E899 82 m 0757530 0098698 T W
w-5% is
0) Designation: E 899 - 82 (Reapproved 1987)
Standard Guide for
Records Management in Mass Spectrometry Laboratories
Performing Analysis in Support of Nonclinical Laboratory
Studies’
This standard is issued under the futed designation E 899; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope
does not include basic exploratory studies carried out to
determine whether a test article has any potential utility or to
1.1 This guide presents a summary of the records needed
determine physical or chemical characteristics of a test
to demonstrate, in a retrospective audit, that scientifically
article,
sound mass spectral data have been generated.
3.3 raw data-any laboratory worksheets, records, mem-
1.2 This guide outlines a set of written laboratory proce-
oranda, notes, or exact copies thereof, that are the result of
dures for the documentation of instrument operation,
original observations and activities of a nonclinical labora-
testing, and maintenance, as weil as for the documentation
tory study and are necessary for the reconstruction and
of the analyses performed.
evaluation of the report of that study. In the event that exact
NOTE 1-For further guidance on instrument operation and labora-
transcripts of raw data have been prepared (for example,
tory procedures refer to Practices E 137 and E 260.
tapes that have been transcribed verbatim, dated, and
1.3 This standard may involve hazardous materials, oper-
verified accurate by signature), the exact copy or exact
ations, and equipment, This standard does not purport to
transcript may be substituted for the original source as raw
address all of the safety problems associated with ifs use. It is
data. Raw data may include photographs, microfdm or
the responsibility of the user of this standard to establish
microfiche copies, computer printouts, magnetic media,
clppropriate safety and health practices and determine the
including dictated observations, and recorded data from
applìcability of regtilatory limitations prior to irse.
automated instruments.
3.4 test article-any food additive, color additive, drug,
2. Referenced Documents
biological product, electronic product, medical product for
human use, or any other article subject to regulation under
2. i ASThí Standards:
the Federal Food, Drug, and Cosmetic Act or under Sections
E 137 Practice for Evaluation of Mass Spectrometers for
35 1 and 354-360F of the Public Health Service Act.
Quantitative Analysis From a Batch Inletz
3.5 test system-any animal, plant, microorganism, or
E 260 Practice for Packed Column Gas Chromatograph?
subparts thereof to which the test or control article is
2.2 Other Documents:
administered or added for study. Test system also includes
Good Laboratory Practice for Nonclinical Laboratory
appropriate groups or components of the system not treated
Studies3
with the test or control articles,
Federal Food, Drug and Cosmetic Act4
Public Health and Safety Act4
4. Significance and Use
3. Definitions
4.1 This standard is intended to provide general guide-
lines to the elements of laboratory records management that
3.1 control article-any article other than the test article
are considered necessary for mass spectrometry laboratories
that is administered to the test system in the course of a
performing analyses regulated by the document “Good
nonclinical laboratory study for the purpose of establishing a
Laboratory Practice for Nonclinical Laboratory Studies.”
basis for comparison with the test article.
4.2 This guide is intended to provide an awareness of
3.2 nonclìnìcal laboratory studies-any in vivo or in vitro
good laboratory practices and procedures. It is not intended
experiment in which a test article is studied prospectively in
to be sufficiently comprehensive to ensure compliance with
a test system under laboratory conditions to determine its
ail current and future regulations.
safety. The term does not include studies utilizing human
subjects or clinical studies or field trials in animals. The term
5. Records Management
5.1 The successful reconstruction of an analysis and the
This guide is under the jurisdiction of ASTM Committee. E-14 on Mass
events surrounding it, in a retrospective audit, require a set
Spectrometry and is the direct responsibility of Subcommittee E14.14 on General
of carefully followed and documented laboratory operating
Practices.
Current edition approved September 24, 1982. Published November 1982. procedures and good records management. Suggested record
’ Anniral Book ofAST.tí Standards. Vol 14.01.
keeping documents and procedures follow.
a Federal Register. Yo1 43, No. 247,
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