QRM

This paper is based on a fireside chat which took in Technological University Dublin, on June 1st at a conference entitled ‘ICH …

A Few Excel and R tools for Quality Risk Management. Many of the tools used in quality risk management can be implemented in spreadsheet software. Spreadsheets are widely accessible and often the preferred way to build a risk management exercise, training example or solution. This project presents several common QRM tools in a spreadsheet format.

Essentially any concept of risk is built on fundamental concepts of chance, likelihood or probability. Although risk is generally a …

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process …

The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule …

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative …

As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; …

Supplementary notes can be added here, including code and math.

Quality risk management for the pharmaceutical industry was recently defined in internationally harmonized guidance as a systematic …