It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Articles

The EC is calling for interested parties for their safety and orphan drug committees.

European Commission Searches for Committee Experts

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

Prasanth Sambaraju is an independent researcher based in Hyderabad, India. 

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. 

Pooling of Batches for Stability Data Analysis

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

Breathing Easier

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

The EU AI Act

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

H. Gregg Claycamp, MS, PhD, is a Risk and Decision Analysis Consultant, hgclaycamp@gmail.com.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making. 

Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel. 

Using a Third Party to Perform Audits

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities. 

FDA Provides Guidance on Remote Facility Evaluations

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments