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 ...

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data. The principles of quality by design (QbD) and life cycle management, as outlined in ...

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 ...

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 ...

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 ...