FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...

Uncertainty is an important analytical and legal issue for reporting WADA Prohibited List threshold substances. Threshold substances require quantitative analysis to compare analytical signal and ...

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 ...

This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product ...

IMGCAP(1)]Documenting audit and review procedures often feels more like administrative than value-adding work. And some procedures—like analytics, for example—require more extensive documentation due ...

Q14 is a new guideline detailing the elements of minimal and enhanced approaches for analytical procedure development. While the traditional minimal development approach remains valid, the advanced ...