Building infrastructure and human capacities

Building infrastructure and human capacities

Harmonised QA/QC in laboratory testing

P-A-R-C aims to promote harmonization and alignment of quality assurance (QA) and quality control (QC) for laboratory tests performed in the context of risk assessment. 

Chemical analysis

The measurement of chemicals in various sample matrices is performed in PARC to generate data for monitoring and exposure assessment. This involves a variety of chemical substance groups and analytical techniques, applied in multiple research domains including:

  • environment (water, sediment, soil, air, indoor dust, etc.),
  • human biomonitoring (urine, blood, hair, breast milk, etc.),
  • food (raw primary products, processed food, etc.).

While definitions and general principles for QA/QC are well established through IUPAC ↗, EURACHEM ↗, ISO ↗, CEN ↗, etc., their interpretation and application in daily laboratory routine vary depending on chemical, technique, research domain, research question, and even between laboratories within the same field. Inconsistencies and/or lack of QA/QC procedures across domains may negatively impact the reliability and comparability of the analysis results. This is a concern, especially when data from different domains are compiled for risk assessment.

Building on the generic principles for QA/QC in chemical analysis, and the domain-specific protocols, guidelines, and infrastructures already existing (e.g. for food via EURL infrastructure on residue and contaminants ↗, and human biomonitoring via HBM4EU ↗), our ambition is to establish harmonised QA/QC procedures and (minimum) criteria for chemical analysis to support risk assessment done in PARC.

How do we do this? As a first step, existing QA/QC procedures in the domains relevant for PARC are inventoried. We review paper protocols and conduct a ‘reality check’ on how things are handled in daily laboratory practice. Inconsistencies and gaps are identified. Based on this, PARC QA/QC guidances and criteria are developed that are scientifically sound yet pragmatic to ensure actual use in daily routines.

The activities are carried out in four working groups: 

  1. Sampling
  2. Analytical method performance criteria
  3. Comparability of analysis results from different laboratories 
  4. Reporting and acceptability of analysis results

For more information, please contact Hans Mol (hans [dot] molatwur [dot] nl) and Renée Van Alst (renee [dot] vanalstatwur [dot] nl).

Toxicity testing

In PARC, toxicodynamic (hazard) and toxicokinetic (ADME characteristics) data are generated. With the exception of the occasional in vivo study, these data will be generated in vitro where possible or ex vivo where needed, and in silico tools will be used. Ensuring good quality of the experimental performance is crucial for the later acceptance of the results, regardless of the method’s Technology Readiness Level (TRL) or regulatory readiness.

For in vivo studies, numerous guidance documents are available, while the number for alternative approaches, such as in vitro and in silico, are more limited (OECD ↗, ECVAM ↗). Initially, we inventorise existing guidance documents that describe QA/QC criteria for 

  • in vitro toxicity studies, 
  • working with nanomaterials, 
  • toxicokinetics (in vitro/ex vivo data generation) and PBK-modelling.

Following this inventory of existing guidance documents, we aim to describe generic QA/QC guidelines and criteria, that can be applied across all PARC activities within a broader remit.

For more information, please contact Johanna Samulin-Erdem (Johanna [dot] Samulin-Erdematstami [dot] no) and Tim Hofer (Tim [dot] Hoferatfhi [dot] no).