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 ...

Parameters affecting cleaning validation swab recovery studies include: the material of construction coupon, residue spike level (s), swab recovering the residue, swab personnel, swab extraction, and ...

The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.

We apply a one-for-all validation procedure to ensure validation robustness with a Six-Sigma confidence interval, independent of the test method or whether this method is used in our manufacturing ...

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 ...