Quality Systems

Articles

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

USP Permits Use of Non-Animal-Derived Reagents for Endotoxin Testing

Jason Boyd is senior director, Veeva Vault LIMS.

Using one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster. 

Getting Lab Data Closer to the Decision Point Keeps Product Release on Track 

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Umit Kartoglu is president and CEO, Extensio et Progressio,
Collonge-Bellerive, Switzerland.

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment. 

QRM, Knowledge Management, and the Importance of ICH Q9(R1)

Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.

Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory Context

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

Here, Pavan Kumar Kunala from Almac Sciences runs through the different types of tests used to analyze drug substances to ensure quality and safety.

Reviewing the Categories of Substance Tests

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

Determination of Shelf-Life from Stability Data: From Replicates or from Averages?

The final drug product relies on the quality and reliability of the raw materials used in its production.

Diversifying the Supply of Raw Materials 

Feliza Mirasol is the science editor for 

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

Cheryl Barton is director of PharmaVision, 

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Using RWD in Non-Interventional Studies

Michaela Doláková is chief microbiologist at SCTbio.

Veronika Horková is microbiologist at SCTbio.

Klára Sochorová is senior quality compliance manager at SCTbio.

Daniela Rožková is chief technology officer at SCTbio.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

Quality Assurance/Quality Control