This is the first in a series of articles discussing the quality control and quality assurance measures for state-of-the-practice toxicity testing by Senior Scientist James Markwiese, PhD. The series will focus on mechanisms to facilitate the establishment and documentation of quality procedures for toxicity testing laboratories. The second article in this series is available here. The third article in this series is available here.
Toxicity tests are used to determine whether materials containing multiple constituents can induce effects upon living organisms. The liability associated with inadequate characterization of toxicity (either over- or under-estimating actual toxicity) can be enormous and the quality of toxicity testing is, therefore, of great importance. While rigorous quality assurance evaluations such as data validation are routine for chemical characterization of samples, analogous toxicity testing quality assurance measures are limited; this lack of QA can present a vulnerability to our clients. Vitale Scientific Associates is taking the necessary steps to ensure that only high-quality and defensible toxicity data are provided.
Successful toxicity testing laboratories need to employ quality management systems to help meet toxicity test acceptability requirements and ensure quality results. Critical components of quality management systems for toxicity testing programs include:
- emphasis on analyst training (particularly with regard to culture and maintenance of test organisms).
- maintenance of standardized operating procedures.
- maintenance of required test conditions.
- use of standard reference toxicants.
- testing multiple control or reference samples with each batch of toxicity tests.
- detailed record-keeping.
- appropriate statistical analyses.
- routine laboratory audits.
Connect with Dr. Markwiese on LinkedIn or at email@example.com.