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 ...

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach. Parameters affecting cleaning ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

Single-use bioreactors have been successfully implemented by the biopharmaceutical industry up to the 2,000-L scale. The performance of single-use bioreactors is comparable if not superior to ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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 ...