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

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

Videos

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan. 

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

Feliza Mirasol is the science editor for 

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

CPHI Milan 2024: Navigating CMC Challenges for GLP-1 and Oral Peptides

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

CPHI Milan 2024: Compliance and Automation in Aseptic Processing

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. 

Using Compendial-Grade Materials for 503B Compounding Facilities

The use of artificial intelligence and machine learning has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.

Barriers to AI Adoption

Cheryl Barton is director of PharmaVision, 

Regulators, EMA and HMA, have published principles and recommendations 
on the use of LLMs, which are being increasingly used for daily tasks.


Responding to the Increased Use of Generative AI

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

This Behind the Headlines news roundup panel discussion discusses news items such as research results from the June Lab at the University of Pennsylvania presented at the Hanson Wade 9th CAR-TCR Summit; winter vaccine recommendations, particularly for respiratory syncytial virus (RSV) and Beyfortus access and deployment; upcoming early October Nobel prize announcement predictions; digital biology analytics, quantitation, alongside point of care (POC) and distributed manufacturing. The panel also talks about the Biosecure Act and manufacturing reshoring; Federal reserve interest rate cuts of a full half a percent (1); and the general investment and financial outlook. 

Behind the Headlines: Winter Vaccine Recommendations; Nobel Prize Predictions; Biosecure Act; and more.

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

FDA Approves Schizophrenia Treatment that Targets Cholinergic Receptors

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Suspends Sickle Cell Disease Medicine

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments