Information about development and validation of methods

Good Cell Culture Practice (GCCP) is a set of six principles intended to support best practice and define minimum standards for cell culture methods. The principles were originally published in 2005 and an updated version, GCCP 2.0, was published in 2022 to include more complex cell culture systems. Both versions are useful in development of cell culture methods.

• Guidance document on Good Cell Culture Practice (GCCP) (sagepub.com)
  

• Guidance document on Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0) (altex.org)
  

Good In Vitro Method Practices (GIVIMP) is a guidance document from the Organization for Economic Co-operation and Development (OECD). GIVIMP combines scientific advances with principles of quality assurance, and is a good tool both for test method developers striving for regulatory usefulness, and for the general scientist wanting to generate robust and reliable data.

• Guidance Document on Good In Vitro Method Practices (GIVIMP) (oecd.org)
  

The EU education and training platform ETPLAS has created an online education module (EU-60) based on the GIVIMP guidance document. The module is free of charge but you have to create an account and login to access the contents.

• Developing in vitro methods and approaches for scientific and regulatory use (EU-60) (etplas.eu)
  

To ensure that other scientists can implement and use the methods that you have developed, they need to be described in sufficient detail in your publication.

Promoting Reusable and Open Methods and Protocols (PRO-MaP) and Reporting In Vitro Experiments Responsibly (RIVER), are two sets of draft recommendations aiming to increase and improve the reporting of detailed protocols for methods used in the life sciences. These draft recommendations outline actions that can be taken by each of four stakeholder groups; researchers, research institutions and departments, publishers and editors, and research funding bodies, in order to produce clear step-by-step protocols for research methods.

• Promoting Reusable and Open Methods and Protocols (PRO-MaP) (osf.io)
  

• Reporting In Vitro Experiments Responsibly (RIVER) recommendations (osf.io)
  

For regulators working with risk assessment to be able to use data from methods that are not part of an established test guideline, the methods need to be clearly described. The Template for the Description of Cell-Based Toxicological Test Methods (ToxTemp), has been developed to help researchers meet the documentation requirements from regulators.

• ToxTemp (altex.org)

The EU reference laboratory EURL ECVAM is tasked to promote and facilitate the use of non-animal methods in research and safety testing. EURL ECVAM is also responsible for formal validation within the EU. EURL ECVAM thus assess and priorities methods that are submitted for validation based on development, optimization, eventual pre-validation as well as potential relevance for the 3Rs. If a method is found relevant and mature enough for validation, EURL ECVAM decides on the type of study needed and coordinates the study. The hands-on laboratory work is conducted in multi-laboratory validation teams, often by laboratories in the EURL ECVAM network of specialized laboratories (EU-NETVAL), where Sweden is represented by RISE Research Institutes of Sweden.

At the EURL ECVAM website you can find information about validation, the method submission process, validated test methods, computational methods, the EU-NETVAL network of specialized laboratories and more. You can also find the form for submission of new test methods.

• Information about validation at EURL ECVAM (europa.eu)
  

• EURL ECVAM test method submission (ec.europa.eu)
  

PEPPER is a public-private platform that acts to speed up validation of methods specifically for evaluation of endocrine disruptors. PEPPER coordinates and helps to fund pre-validation studies to promote further validation and regulatory acceptance.

• PEPPER validation and prevalidation (ed-pepper.eu)
  

The PEPPER platform has produced a Self Assessment Questionnaire (SAQ) to assess the readiness of your method for characterization of endocrine disruptors with respect to validation. This is called the ReadEDTest and is formed like a checklist for in vitro methods.

• ReadEDTest self assessment questionnaire (u-paris-sciences.fr)
  

The OECD is an international organization that works to build better policies for better lives in many different areas.

In the area of risk assessment of chemicals, the OECD works globally to standardize and harmonize guidelines to ensure reliable data.

The OECD has described the validation process in guidance document number 34 (GD34). This document is currently being updated and a new version will soon be available.

• Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment (GD34) (oecd.org)

A validation study should preferably be performed in a quality assured work flow, ensuring data integrity and the possibility to reconstruct the study. The OECD also provides guidance on the quality system Good Laboratory Practice (GLP) which can be used for this purpose.

• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1 (1998) (oecd-ilibrary.org)

More guidance documents that can be relevant for the validation process are found below.

• Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals (GD1) (oecd.org)
  
• Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways (GD184) (oecd.org)
  
• Guidance Document for Describing Non-Guideline in vitro test methods (GD211) (oecd.org)
  
• Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) (GD260) (oecd.org)
  

A complete list of available OECD publications of test guidelines, can be found here:

• Series on Testing and Assessment: publications by number (oecd.org)
  

The OECD also provides webinars with information on validation. Some of the webinars are directed towards researchers with only little or no previous knowledge on method validation. Other webinars are directed towards regulators.

• OECD Webinar series on testing and assessment methodologies (oecd.org)
  
• OECD Webinar Series on Emerging Science to Improve Chemical Safety (oecd.org)