Quality Systems

Feliza Mirasol is the science editor for 

Articles

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Meeting Adventitious Agent Testing Needs for Complex Modalities

Donald Singer is principle microbiology global consultant at Ecolab Life Sciences.

Tony Cundell is principal consultant at Microbiological Consulting.

The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.

The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing

Manual and automated inspection technologies have their own advantages and limitations.

Considerations for Finished Product Inspection Systems

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 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.

Quality Assurance/Quality Control