Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s ...

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen. Validation failures, just like out-of-specification (OOS) ...

Submitted: October 12, 2015 Accepted: December 2, 2015. Parameters affecting cleaning validation swab recovery studies include: the material of construction coupon, residue spike level(s), swab ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

CSIR-CCMB’s novel ‘Dry Swab’, extraction-free direct RT-PCR testing method, which has reduced the time taken for the COVID test result to be declared, got further validation with another study ...

AOAC INTERNATIONAL announced today that it has issued Certificates of Validation for three proprietary test kits that detect SARS-CoV-2, the causative agent of COVID-19 illness, on environmental ...

We describe Exome Cancer Test v1.0 (EXaCT-1), the first New York State-Department of Health-approved whole-exome sequencing (WES)-based test for precision cancer care. EXaCT-1 uses HaloPlex (Agilent) ...