Category: Article

This category can only be viewed by members. To view this category, sign up by purchasing MEMBER PLUS +.

The Big Reshuffle — Impact Assessments and System Criticality

A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of […]

To access this post, you must purchase MEMBER PLUS +.

Read More »

Risk Management Tied Up With A Bow Tie

Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve product […]

To access this post, you must purchase MEMBER PLUS +.

Read More »