ASTM E2549-09

Standard Practice for Validation of Seized-Drug Analytical Methods

SIGNIFICANCE AND USE
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that address the topic of validation but there are few validation protocols for methods specific to seized drug analysis. This standard makes recommendations for the validation of both qualitative and quantitative methods used for the analysis of seized drugs.
SCOPE
1.1 This practice addresses the validation of qualitative and quantitative seized-drug analytical methods. It discusses the validation of analytical methods in terms of their part in analytical schemes and in terms of performance characteristics including brief mention of measurement uncertainty and quality control parameters.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Mar-2009
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: E30 - Forensic Sciences
• Drafting Committee: E30.01 - Criminalistics

Relations

• Referred By: ASTM E2882-19 - Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
• Effective Date: 01-Apr-2009
• Referred By: ASTM E2329-17 - Standard Practice for Identification of Seized Drugs
• Effective Date: 01-Apr-2009
• Referred By: ASTM E2327-15e1 - Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis (Withdrawn 2024)
• Effective Date: 01-Apr-2009

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E2549 − 09
StandardPractice for
Validation of Seized-Drug Analytical Methods
This standard is issued under the fixed designation E2549; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.6 Verification should, at a minimum, demonstrate that a
representative set of reference materials has been carried
1.1 This practice addresses the validation of qualitative and
through the process and yielded the expected results.
quantitative seized-drug analytical methods. It discusses the
validation of analytical methods in terms of their part in
4. Individual Laboratory Responsibility
analytical schemes and in terms of performance characteristics
4.1 Each laboratory should determine whether their current
including brief mention of measurement uncertainty and qual-
standard operating procedures have been validated, verified or
ity control parameters.
require further validation/verification.
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
5. Operational Environment
responsibility of the user of this standard to establish appro-
5.1 Allmethodsshallbevalidatedorverifiedtodemonstrate
priate safety and health practices and determine the applica-
that they will perform in the normal operational environment
bility of regulatory limitations prior to use.
when used by individuals expected to utilize the methods on
casework.
2. Significance and Use
2.1 Validation is the confirmation by examination and the
6. Documentation
provisionofobjectiveevidencethattheparticularrequirements
6.1 The entire validation/verification process shall be docu-
for a specific intended use are fulfilled. There are numerous
mented and the documentation shall be retained. Documenta-
documents that address the topic of validation but there are few
tion shall include, but is not limited to the following:
validation protocols for methods specific to seized drug analy-
6.1.1 personnel involved,
sis.This standard makes recommendations for the validation of
6.1.2 dates,
both qualitative and quantitative methods used for the analysis
6.1.3 observations from the process,
of seized drugs.
6.1.4 analytical data,
6.1.5 a statement of conclusions and/or recommendations,
3. Analytical Scheme
and
3.1 An analytical scheme shall be comprised of validated
6.1.6 authorization approval signature.
methods that are appropriate for the analyte.
7. Recommendation
3.2 The combinations of methods chosen for a particular
analytical scheme shall identify the specific drug of interest,
7.1 To meet the requirements of sections 4 through 6,itis
preclude a false positive and minimize false negatives.
recommended that laboratories follow the applicable provi-
sions of Section 8 [General Validation Plan] when validating
3.3 For quantification the method should reliably determine
seized-drug analytical methods.
the amount of analyte present.
NOTE 1—For further information, see Supplemental Documents SD-2
3.4 If validated methods are used from published literature
“Preparing Validation Plans, Section I: Analytical Techniques – Elements
or another laboratory’s protocols, then the methods shall be
to Consider” and Section II: “Example Validation Plan for GC/MS
Identification and Quantitation of Heroin,” SWGDRUG.
verified within each laboratory
3.5 If non-routine validated methods are used, then the
8. General Validation Plan
method shall be verified prior to use.
8.1 Purpose/Scope—This is an introductory statement that
will specify what is being tested, the purpose of the testing and
the result(s) required for acceptance.
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
8.1.1 Performance Specification—A list of specific objec-
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
tives (for example, trueness and precision) should be deter-
Current edition approved April 1, 2009. Published June 2009. DOI: 10.1520/
E2549-09. mined prior to the validation process.
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E2549 − 09
NOTE 2—Reproducibility determination may be limited to studies
8.1.2 Process Review—After completion of the validation
within the same laboratory.
process the objectives should be revisited to ensure that they
(1) Within the scope of the validation, determine accept-
have been satisfactorily met.
able limits for repeatability and reproducibility.
8.2 Analytical Method—State exactly the method to be
(2) For qualitative analysis run the qualitative method a
validated. It is essential that each step in the method be
minimum of ten times.
demonstrated to perform satisfactorily. Steps that constitute a
(3) For quantitative analysis run the quantitative method a
method for the identification and/or quantification of seized
minimum of ten times.
drugs may include:
(4) Validation criteria for non-r
...