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. And some procedures—like analytics, for example—require more extensive documentation due ...

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 ...

Most companies, big and small, are subject to an audit at some point. Auditors can focus on one or more areas, such as your financial statements, compliance, tax information or business operations.

Approved by the Royal Society of Chemistry for purposes of continuing professional development (CPD). The course will provide you with the requisite scientific knowledge and understanding of ...