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ASTM E2549-14

(Practice)

Standard Practice for Validation of Seized-Drug Analytical Methods (Withdrawn 2023)

Standard Practice for Validation of Seized-Drug Analytical Methods (Withdrawn 2023)

SIGNIFICANCE AND USE
3.1 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 practice 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 practice does not replace knowledge, skill, ability, experience, education or training and should be used in conjunction with professional judgment.  
1.3 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.
WITHDRAWN RATIONALE
This practice addressed the validation of qualitative and quantitative seized-drug analytical methods. It discussed 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.
Formerly under the jurisdiction of Committee E30 on Forensic Sciences, this practice was withdrawn in July 2023 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
28-Feb-2014
Withdrawal Date
09-Jul-2023
ICS
11.100.01 - Laboratory medicine in general
Technical Committee
E30 - Forensic Sciences
Drafting Committee
E30.11 - Interdisciplinary Forensic Science Standards
Current Stage
Ref Project

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ASTM E2549-14 - Standard Practice for Validation of Seized-Drug Analytical Methods (Withdrawn 2023)ASTM E2549-14 - Standard Practice for Validation of Seized-Drug Analytical Methods (Withdrawn 2023)
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ASTM E2549-14 - Standard Practice for Validation of Seized-Drug Analytical Methods (Withdrawn 2023)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2549 − 14 An American National Standard
Standard Practice for
1
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 4. Analytical Scheme
1.1 This practice addresses the validation of qualitative and 4.1 An analytical scheme shall be comprised of validated
quantitative seized-drug analytical methods. It discusses the methods that are appropriate for the analyte.
validation of analytical methods in terms of their part in
4.2 The combinations of methods chosen for a particular
analytical schemes and in terms of performance characteristics
analytical scheme shall identify the specific drug of interest,
including brief mention of measurement uncertainty and qual-
preclude a false positive and minimize false negatives.
ity control parameters.
4.3 For quantification the method should reliably determine
1.2 This practice does not replace knowledge, skill, ability,
the amount of analyte present.
experience, education or training and should be used in
4.4 If validated methods are used from published literature
conjunction with professional judgment.
or another laboratory’s protocols, then the methods shall be
1.3 This standard does not purport to address all of the
verified within each laboratory
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 4.5 If non-routine validated methods are used, then the
priate safety and health practices and determine the applica- method shall be verified prior to use.
bility of regulatory limitations prior to use.
4.6 Verification should, at a minimum, demonstrate that a
representative set of reference materials has been carried
2. Referenced Documents
through the process and yielded the expected results.
2
2.1 ASTM Standards:
E2327 Practice for Quality Assurance of Laboratories Per- 5. Individual Laboratory Responsibility
forming Seized-Drug Analysis
5.1 Each laboratory should determine whether their current
E2764 Practice for Uncertainty Assessment in the Context of
standard operating procedures have been validated, verified, or
Seized-Drug Analysis
require further validation/verification.
3. Significance and Use
6. Operational Environment
3.1 Validation is the confirmation by examination and the
6.1 All methods shall be validated or verified to demonstrate
provision of objective evidence that the particular requirements
that they will perform in the normal operational environment
for a specific intended use are fulfilled. There are numerous
when used by individuals expected to utilize the methods on
documents that address the topic of validation but there are few
casework.
validation protocols for methods specific to seized drug analy-
sis. This practice makes recommendations for the validation of
7. Documentation
both qualitative and quantitative methods used for the analysis
7.1 The entire validation/verification process shall be docu-
of seized drugs.
mented and the documentation shall be retained for a period in
accordance with laboratory policy. Documentation shall
include, but is not limited to the following:
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
7.1.1 Personnel involved;
Sciences and is the direct responsibility of Subcommittee E30.11 on Interdisciplin-
ary Forensic Science Standards.
7.1.2 Dates;
Current edition approved March 1, 2014. Published March 2014. Originally
7.1.3 Observations from the process;
approved in 2009. Last previous edition approved in 2009 as E2549 – 09. DOI:
7.1.4 Analytical data;
10.1520/E2549-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
7.1.5 A statement of conclusions or recommendations, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
both; and
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 7.1.6 Authorization approval signature.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2549 − 14
8. Recommendation 9.4.2 Matrix Effects—Assess the impact of any interfering
components and demonstrate that the method works in the
8.1 To meet the requirements of Sections 4 through 7, it is
presence of substances that are commonly encountered in
recommended that laboratories follow the applicable provi-
seized drug samples (for example, cutting agents, impurities,
sions of Section 9 [Gene
...

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SIGNIFICANCE AND USE
4.1 This guide is designed to assist medical device manufacturers as they develop new devices or qualify existing devices (e.g., catheters, needles) for delivering clinical cell therapies. Cytocompatibility considers the impact of the delivery device on the cells passing through the device during the delivery procedure. The biological safety of the device (e.g., the device’s cytotoxicity) should be addressed via other methods, such as ISO 10993-5. It is understood that this guide does not address testing of specific cellular products with specific delivery devices. Such testing may be required by regulatory authorities prior to clinical trial of cellular product or marketing applications. This guide outlines considerations to make the product qualification procedures more likely to succeed and more cost effective.  
4.2 The key aspects of assessing device cytocompatibility include selecting a test cell line or cell lines and determining the cell physiology parameters that will be measured to make a determination of cytocompatibility. Acceptance criteria for designating a device as cytocompatible are not detailed here. It will be up to the delivery device end user to determine if the results of a cytocompatibility assessment are sufficient to consider that device cytocompatible. Delivery device lot to lot variability may impact cytocompatibility, therefore validated manufacturing processes should be considered when producing devices for cytocompatibility assessments.
SCOPE
1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (e.g., tissue grafting) are not included in the scope of this document. This document does not address physical characterization of delivery devices, such as mechanics, composition, or degradation.  
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.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
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