Framework for the quality assurance of 'omics technologies considering GLP requirements
File(s)1-s2.0-S0273230017303094-main.pdf (1.23 MB)
Published version
Author(s)
Type
Journal Article
Abstract
‘Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing ‘omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying ‘omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective ‘omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should be validated, and data changes should be traceable or disabled. GLP-compliant quality assurance of ‘omics technologies appears feasible for many GLP requirements. However, challenges include (i) defining, storing, and archiving the raw data; (ii) transparent descriptions of data processing steps; (iii) software validation; and (iv) ensuring complete reproducibility of final results with respect to raw data. Nevertheless, ‘omics studies can be supported by quality measures (e.g., GLP principles) to ensure quality control, reproducibility and traceability of experiments. This enables regulators to use ‘omics data in a fit-for-purpose context, which enhances their applicability for risk assessment.
Date Issued
2017-10-05
Date Acceptance
2017-10-04
Citation
Regulatory Toxicology and Pharmacology, 2017, 91, pp.S27-S35
ISSN
0273-2300
Publisher
Elsevier
Start Page
S27
End Page
S35
Journal / Book Title
Regulatory Toxicology and Pharmacology
Volume
91
Copyright Statement
© 2017 Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, Legal
Pharmacology & Pharmacy
Toxicology
Legal Medicine
Good laboratory practice (GLP)
Standard operating procedure
Independent quality assurance
Documentation
Data storage
Reproducibility
Raw data definition
Software validation
Quality assurance inspection
METABOLOMICS
TOOL
Publication Status
Published