How a GIVIMP certification program can increase confidence in in vitro methods
Open accessAbstract
build confidence in the method developer, the method itself, and the laboratories performing it. Why use GIVIMP for quality standards?Good Laboratory Practice (GLP) (OECD, 1998) and Good Cell Culture Practice (GCCP) (Coecke et al., 2005;Pamies et al., 2020) provide important topics to consider, but neither serves as a comprehensive quality framework for the development or execution of in vitro methods.Although GLP's focus on the reproducibility of non-clinical studies is important, its requirements do not always fit in vitro methods (Cooper-Hannon et al., 1999), and critical elements to maintain reliable and reproducible results for in vitro methods are missing (OECD, 2004).Similarly, while GCCP guidelines provide reference for designing and implementing procedures for cells and tissues, they do not include full method (i.e., assay) specific concerns.GCCP guidelines also do not ex-
AI snapshot
Written from the paper’s full text.
TL;DR
This commentary argues that the OECD's Good In Vitro Method Practices (GIVIMP) guidance is a comprehensive but unwieldy 260-page quality framework, and that a certification program is needed to harmonize its interpretation and implementation. It describes the Institute for In Vitro Sciences (IIVS) GIVIMP Certification Program, developed with input from BASF SE, which offers "GIVIMP Verified" and "GIVIMP Certified" designations.
Key findings
- GIVIMP was coordinated by EURL ECVAM and officially adopted by the OECD in 2018; it is described as a comprehensive quality framework covering all stages of an in vitro method's life cycle, from development and validation to acceptance and data generation.
- GLP and GCCP each provide relevant topics but neither is a comprehensive quality framework for in vitro methods: GLP requirements "do not always fit in vitro methods" and omit critical elements for reliable in vitro results, while GCCP does not cover full method (assay)-specific concerns.
- GIVIMP is a 260-page document including annexes such as GCCP, and not all guidance applies to every method or laboratory, making implementation difficult and time-consuming even for GLP- and/or ISO-certified laboratories.
- The IIVS program defines "core competencies" for each GIVIMP area; laboratories meeting them are "GIVIMP Verified" (facility or method), and those meeting additional criteria beyond the core competencies are "GIVIMP Certified." It is explicitly not a single-point pass/fail assessment but an iterative process with re-assessment.
Methods
- Commentary/perspective piece; no empirical study, dataset, or formal analysis is reported.
- Describes the rationale, development, and structure of the IIVS GIVIMP Certification Program, which was developed with collaboration from the Experimental Toxicology and Ecology laboratory and quality assurance group of BASF SE.
- Describes program mechanics: assessment by a qualified IIVS-assigned auditor, a comprehensive report comparing facility processes to GIVIMP, specific improvement recommendations, re-assessment after recommendations are followed, and periodic re-assessments to maintain certification.
Limitations
- Stated: the authors declare a conflict of interest — Amanda Ulrey and Erin Hill are employed by the Institute for In Vitro Sciences, Inc., a non-profit that "will charge a service fee to support this certification program."
- Evident from the text: no empirical data, pilot results, or evaluation of the certification program's effectiveness are presented; the article is a program description and rationale rather than an assessment of outcomes.
- Evident from the text: the claim that certification prevents "erosion" or "abandonment" of GIVIMP principles is asserted rather than demonstrated, and the program's core competencies and assessment criteria are not specified in the article.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
2 of 12 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured
- Premisecitation
Regulatory bodies, validation authorities, method developers, and industry toxicologists realize the need to increase confidence in the scientific validity of novel in vitro methods, especially those proposed for regulatory application.
“Regulatory bodies, validation authorities, method developers, and industry toxicologists realize the need to increase confidence in the scientific validity of novel in vitro methods -especially those being proposed for regulatory application (Patterson et al., 2021).”
Quote in the paperSubstantial claim1 of 1 sources checked- cites Patterson et al., 2021 source
- Interpretationcitation
Data reviewers, e.g., companies and regulatory agencies responsible for product registrations, will have increased confidence in data generated in laboratories adhering to GIVIMP standards.
“Also, data reviewers, e.g., companies and regulatory agencies responsible for product registrations, will have increased confidence in data generated in laboratories adhering to GIVIMP standards (Bas et al., 2021).”
Quote in the paperSubstantial claim1 of 1 sources checked- cites Bas et al., 2021 source
Section 2.1.1 (The OECD; page unavailable) says GIVIMP provides practices for laboratories generating test data and aims to reduce uncertainty in in vitro predictions. That supports the rationale for greater confidence, but the paper does not say that companies or regulatory agencies reviewing product registrations will have increased confidence in data from GIVIMP-adherent laboratories. (LLM, conf=0.81)
Experimental — accuracy not yet measured
- Interpretationreasoning
IIVS has developed a GIVIMP Certification Program which will provide guidance on implementation of the quality principles.
“To overcome these challenges, the Institute for In Vitro Sciences (IIVS) has developed a GIVIMP Certification Program which will provide guidance on implementation of the quality principles.”
Quote in the paperSubstantial claim
- Classified as probably not a substantial claim. 16
- May combine two claims. 12
Probably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningThis process assists smaller laboratories with limited resources or experience to participate in the program and improve their quality framework in a managed way.
“This process assists smaller laboratories with limited resources or experience to participate in the program and improve their quality framework in a managed way.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisereasoningGLP and GCCP provide important topics to consider, but neither serves as a comprehensive quality framework for the development or execution of in vitro methods.
“Good Laboratory Practice (GLP) (OECD, 1998) and Good Cell Culture Practice (GCCP) (Coecke et al., 2005;Pamies et al., 2020) provide important topics to consider, but neither serves as a comprehensive quality framework for the development or execution of in vitro methods.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites OECD, 1998
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites Coecke et al., 2005 source
- cites Pamies et al., 2020
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S4 (based). May combine two claims.
PremisereasoningGIVIMP is recognized as internationally harmonized guidance, but it is not a regulatory standard and thus no government authority is responsible for overseeing the implementation of its recommendations.
“While GIVIMP is recognized as internationally harmonized guidance, it is not a regulatory standard and thus no government authority is responsible for overseeing the implementation of its recommendations.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningResearchers new to quality frameworks and even experienced laboratories will spend resources to determine the most relevant principles to follow and the best course to implement them.
“Researchers new to quality frameworks and even experienced laboratories (e.g., those certified for GLP and/or ISO standards) will spend resources to determine the most relevant principles to follow and the best course to implement them.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisereasoningNot all guidance in GIVIMP is applicable to every method and laboratory.
“Not all guidance is applicable to every method and laboratory.”
- Also stated in: § Abstract · plain
“While a broad range of topics is covered within the guidance, not all recommendations are applicable to every developer, method or laboratory.”
Quote in the paperSubstantial claim- Also stated in: § Abstract · plain
Probably not a substantial claim: may not pass S2 (checkable), S4 (based).
InterpretationreasoningA certification program that provides guidance on which standards to prioritize and recommendations on how to achieve compliance transforms the sizeable GIVIMP guidance into a manageable, systematic approach for improving laboratory processes and creating a quality framework.
“A certification program that provides guidance on which standards to prioritize and recommendations on how to achieve compliance transforms the sizeable GIVIMP guidance into a manageable, systematic approach for improving laboratory processes and creating a quality framework.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationGCCP guidelines provide reference for designing and implementing procedures for cells and tissues but do not include full method-specific concerns.
“Similarly, while GCCP guidelines provide reference for designing and implementing procedures for cells and tissues, they do not include full method (i.e., assay) specific concerns.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Coecke et al., 2005 source
- cites Pamies et al., 2020
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S4 (based). May combine two claims.
InterpretationreasoningParticipation in the GIVIMP Certification Program will demonstrate adherence to essential quality standards and will result in practical benefits for both the method developer and data user.
“Participation in the program will demonstrate adherence to essential quality standards and will results in practical benefits for both the method developer and data user.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationGLP requirements do not always fit in vitro methods, and critical elements to maintain reliable and reproducible results for in vitro methods are missing from GLP.
“Although GLP's focus on the reproducibility of non-clinical studies is important, its requirements do not always fit in vitro methods (Cooper-Hannon et al., 1999), and critical elements to maintain reliable and reproducible results for in vitro methods are missing (OECD, 2004).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Cooper-Hannon et al., 1999
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites OECD, 2004
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Classified as probably not a substantial claim.
PremisecitationThe OECD guidance document GIVIMP stands as a comprehensive quality framework that provides recommendations for all stages of an in vitro method's life cycle: from development and validation to acceptance and use in the generation of data for decision-making.
“The resulting Organization for Economic Cooperation and Develop ment (OECD) guidance document, Good In Vitro Method Practices (GIVIMP) (OECD, 2018), stands as a comprehensive quality framework that provides recommendations for all stages of an in vitro method's life cycle: from development and validation to acceptance and use in the generation of data for decision-making.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites OECD, 2018
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
PremisecitationGIVIMP is internationally recognized and was officially adopted by the OECD as a guidance document in 2018.
“GIVIMP is internationally recognized and was officially adopted by the OECD as a guidance document in 2018 (OECD, 2018).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites OECD, 2018
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenAdherence to the principles in GIVIMP provides the data user confidence in the new methods and generated in vitro data.
“Adherence to the principles in GIVIMP provides the data user confidence in the new methods and generated in vitro data.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Premisenone givenThe core competencies of the GIVIMP Certification Program are applicable to both the development of a single method and the overall organization of laboratory operations.
“These core competencies are applicable to both the development of a single method and the overall organization of laboratory operations.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
InterpretationreasoningWith periodic re-assessments to maintain certification, laboratories will be alerted of any drift from compliance and updated on application of GIVIMP to regulatory and technological advancements.
“With periodic re-assessments to maintain certification, laboratories will be alerted of any drift from compliance and updated on application of GIVIMP to regulatory and technological advancements.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
PremisecitationGIVIMP incorporates the relevant elements of both GLP and GCCP and includes guidance on the execution of the entire test method including the use of reference materials and the determination of appropriate acceptance criteria for the method/assay.
“GIVIMP incorporates the relevant elements of both GLP and GCCP (Fig. 1) and includes guidance on the execution of the entire test method including the use of reference materials and the determination of appropriate acceptance criteria for the method/ assay.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites OECD, 2018
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Classified as probably not a substantial claim. May combine two claims.
Interpretationnone givenThe GIVIMP Certification Program gives structure and consistency to the application of GIVIMP standards and assists laboratories to apply them.
“The GIVIMP Certification Program gives structure and consistency to the application of GIVIMP standards and assists laboratories to apply them.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningGiven the breadth and depth of GIVIMP, it may be difficult and/or time consuming for researchers and in vitro laboratories to implement.
“However, given the breadth and depth of GIVIMP, it may be difficult and/or time consuming for researchers and in vitro laboratories to implement.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningSmall and large facilities, academic laboratories, contract research organizations, governmental and industry laboratories can all participate in, and benefit from, the assessment process.
“Small and large facilities, academic laboratories, contract research organizations, governmental and industry laboratories can all participate in, and benefit from, the assessment process.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
InterpretationreasoningWithout such a certification program, claims of successful application of GIVIMP will be left to individual interpretation, which could lead to erosion of the concepts and intent of the documented standards or even to the abandonment of these important principles and their intended benefits for the in vitro community.
“Without such a certification program, claims of successful application of GIVIMP will be left to individual interpretation, which could lead to erosion of the concepts and intent of the documented standards -or even to the abandonment of these important principles and their intended benefits for the in vitro community.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningThe structure of the GIVIMP Certification Program is flexible so that it is feasible for all sizes and types of in vitro laboratories.
“The structure of the GIVIMP Certification Program is flexible so that it is feasible for all sizes and types of in vitro laboratories.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Many methods proposed for validation or regulatory consideration need significant improvement before they can be properly evaluated, resulting in delays or failures in acceptance.
“While the demand for these new methods is increasing, many methods that are proposed for validation or regulatory consideration have been found to need significant improvement 1 before they can be properly evaluated -thus resulting in delays, or even failures, in the acceptance process.”
The paper relies on this without support.
Validation bodies and regulatory agencies will expect adherence to GIVIMP to ensure that proposed methods are fit for validation and regulatory acceptance.
“It is anticipated that validation bodies and regulatory agencies will expect adherence to GIVIMP to ensure that the proposed method is fit for validation and, ultimately, regulatory acceptance.”
The paper relies on this without support.
IIVS is a GLP-compliant laboratory familiar with auditing and applying quality standards to in vitro methods.
“As a GLP-compliant laboratory, IIVS is familiar with auditing and applying quality standards to in vitro methods.”
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- Authors
- Ulrey, A.
- Affiliations
- Institute for In Vitro Sciences (US)
- Corresponding author
- Ulrey, Amanda
- Venue
- ALTEX
- Publisher
- ALTEX Edition
- Published
- 2021
- Volume
- 38
- Issue
- 2
- Pages
- 316-318
- ISSN
- 0946-7785 (ISSN-L)
- 1868-596X
- OpenAlex
- W3156258495
- Cited by
- 17
- References
- 9
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 3 · 2023: 6 · 2022: 5
- FWCI
- 3.85
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- ALTEX (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Social Sciences › Business, Management and Accounting › Strategy and Management › Quality and Management Systems
- Keywords
- method validation, assay reproducibility, method reliability, good laboratory practice
- MeSH terms
- Certification
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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