Do Your Materials Testing Labs Have GLP Certification?
Element often receives questions regarding our certifications from our current or prospective clients. On occasion, we will receive questions regarding Good Laboratory Practices (GLP) Certification, including: what is GLP certification? Do you have GLP Certification? Do I need my materials testing performed by a lab that is GLP certified?
These are important questions for a producer/manufacturer to ask. Material testing can be a time consuming and costly endeavor; so ensuring results will be accepted by the governing body in our clients’ respective industries is important.
What is GLP?
The definition of GLP is generally defined as “a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests”.
Another helpful definition of GLP can be found on The Medicines and Healthcare products Regulatory Agency (MHRA) website: “Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides.
GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.”
What Does this Mean for Materials Testing?
Based on these definitions, generally, GLP applies to testing in the pharmaceuticals and environmental spaces. GLP is not intended to govern the types of material testing that most Element labs perform.
While GLP can be a beneficial set of principles for toxicity and bio-burden testing, for materials testing ISO 17025 is generally the most stringent and widely accepted quality accreditation.
ISO 17025 Certification is issued by independent laboratory accreditation bodies. In order to obtain this certification, these agencies perform a thorough, bi-annual audit of our laboratories and testing services to the requirements of ISO 17025.
Although the purpose and guiding principles that dictate GLP compliance and ISO 17025 are similar (to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of test results), for a materials testing service provider, the practices required by an ISO 17025 are more demanding than GLP, and provide greater security in accuracy of data and results.