Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

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 ...

Even with technology changing faster than validation procedures can be rewritten, it still is possible to perform thorough product testing. With the ever-changing complexity of automotive electronics ...

Analytical methods and tools play a pivotal role in cleaning validation. Validating the effectiveness of the cleaning of pharmaceutical manufacturing and process equipment is part of good ...

Representing the most recent generation of double-data-rate (DDR) SDRAM memory, DDR4 and low-power LPDDR4 together provide improvements in speed, density, and power over DDR3. However, such speed and ...