This webinar provides a broad overview of ICH Q10, The Pharmaceutical Quality System. ICH Q10 is applicable throughout the pharmaceutical lifecycle. Unlike the FDA Quality Systems Approach limited ...

An important aspect of a pharmaceutical company is a robust quality management system (QMS) because it shows the company’s commitment to quality. This idea was introduced by the International ...

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical ...

Pharmaceutical and biotechnology companies generate mountains of data that need to be interpreted into information to make decisions. Knowledge about product quality and patient safety need to be ...

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel. Q: We read in an article (1) that there are no specific ...

The latest ICH guideline, Q14, complements Q2(R2) for the validation of analytical procedures. Revision of Q2(R1) into Q2(R2) aligns its implementation with Q14(1), ensuring coherence between both ...

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment. It is important to understand the differences between risk-based ...