Uniform, globally accepted greenness metrics are positioned as essential; inconsistent scoring frameworks would erode ...

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 ...

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

Analytical performance should lead method decisions, but optimization can still reduce solvent, energy, and waste provided ...

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 ...

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 ...

Figure 1 shows that individual measurement values hover around a mean value and the difference between the mean value and true value is the systematic error of ...