Laboratory Requirements for the FDA LAAF Accreditation Program
What Is the FDA LAAF-Accreditation Program? Under the Federal Food, Drug and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has established the…
NELAC and NELAP – What Do These Acronyms Mean for the Environmental Laboratory?
What Is NELAC? NELAC stands for the National Environmental Laboratories Accreditation Conference. Established by the EPA in 1995 as a means to bring consistency in…
The Importance Of Bioburden Testing
Bioburden testing is a critical component for medical device manufacturing to ensure the safety of the product and the user. Why Is Bioburden Testing Important?…
Implementing Beneficial Laboratory Practices
Implementing beneficial laboratory practices enhances confidence in the data generated by the laboratory, which helps bolster its reputation. Beneficial laboratory practices also improve productivity and…
The Anatomy of a Laboratory Assessment
An assessment is a demonstration by a body that specified requirements are fulfilled. Assessments are performed by technically competent assessors who evaluate the competence of…
ISO 20387:2018 – General Requirements for Biobanking
For over 100 years, human specimens have been collected and stored for research purposes. The initial specimen banks based their operations on the needs of…
21 CFR Part 58: GLP for Nonclinical Laboratories
What Is 21 CFR Part 58? 21 CFR Part 58, Good Laboratory Practices for Nonclinical Laboratory Studies, prescribes good laboratory practices, or GLP, for conducting…
IEC Test Report Forms (TRFs)
International Electrotechnical Commission (IEC) test reports forms (TRFs) help laboratories save time and money. This is because IEC TRFs contain all the required specifications on…
What Is ISO 17043?
Laboratory errors have a reported frequency of 0.012–0.6 % of all test results. This is why proficiency testing (PT), a formal type of interlaboratory comparisons, is an…