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Framework for the quality assurance of 'omics technologies considering GLP requirements.

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.

SUBMITTER: Kauffmann HM

PROVIDER: S-EPMC6816020 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Framework for the quality assurance of 'omics technologies considering GLP requirements.

Kauffmann Hans-Martin HM Kamp Hennicke H Fuchs Regine R Chorley Brian N BN Deferme Lize L Ebbels Timothy T Hackermüller Jörg J Perdichizzi Stefania S Poole Alan A Sauer Ursula G UG Tollefsen Knut E KE Tralau Tewes T Yauk Carole C van Ravenzwaay Ben B

Regulatory toxicology and pharmacology : RTP 20171005

'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 ...[more]

PMID: 28987912

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Project description:BACKGROUND:The spread of substandard and falsified (SF) medical products constitutes a growing global public health concern. Some countries use portable, handheld screening technologies (STs) in the field to accelerate detection of SF medicines and reduce the number of medicine samples that undergo costly and time-consuming confirmatory analysis. METHODS:A multi-country, multi-stakeholder landscape assessment utilizing qualitative methodology was used to examine practices and perceptions related to the use of STs. Qualitative interview guides were designed using the results of a literature review and comprised of open-ended questions with the study participants, who were from national medicine regulatory authorities, pharmaceutical manufacturers, pharmacies, and distributors. Ten geographically and economically diverse countries were selected: Argentina, China, Egypt, India, Jordan, Mexico, Nigeria, Philippines, the United States, and Zimbabwe. Of the completed 53 interviews, 32 were in-person, 16 were phone interviews, and 5 were via written questionnaires. RESULTS:Data analysis shows a wide variation in understanding and usage of STs in different sectors. Virtually all of the study participants indicated a lack of objective, accessible information on STs to advise them on what technologies would be beneficial for their needs. Study participants also described their ideal capabilities of the next generation of STs, including shareable spectral libraries, lower acquisition costs, lesser training requirements, and in-country maintenance and technical support. CONCLUSION:The results and recommendations presented in this article can be used to help regulators communicate and justify their needs to acquire and invest in new STs. There is a need for additional standardized, trustworthy and scientifically sound evaluations of STs, and to support regulators to effectively deploy the most promising technologies. ST manufacturers can take into account some of the limitations of the technologies the interviewees identified in this article, such as a dearth of technologies, which provide quantitative information about the active ingredient, and take steps to address them to better serve their customers. These results and recommendations, can catalyze research and actionable interventions into the development, review, application, and use of STs.

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Framework for the quality assurance of 'omics technologies considering GLP requirements.

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Framework for the quality assurance of 'omics technologies considering GLP requirements.

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