Quality Systems
Europe Publishes Electronic Product Information for Selected Medicines
November 09, 2023
Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.
FDA Publishes Guidance on Container Closure Systems for COVID-19
November 09, 2023
The document includes recommendations for the reporting and implementation of changes to container closure system components.
Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360)
November 06, 2023
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.
Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)
November 03, 2023
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.
New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval
November 03, 2023
This is the second biologic approved to treat HS, a painful and reoccurring skin disease.
European Commission Searches for Committee Experts
November 03, 2023
The EC is calling for interested parties for their safety and orphan drug committees.
ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA
November 03, 2023
According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.
Pooling of Batches for Stability Data Analysis
November 03, 2023
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.
Breathing Easier
November 02, 2023
A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.
The EU AI Act
November 02, 2023
The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.