Quality Systems

Particle Measuring Systems Announce Acquisition of Environmental Monitoring Services Limited and EMS Particle Solutions

October 04, 2023

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

In a Digital Gold Rush, Data Integrity is Priceless

October 04, 2023

Data integrity is crucial in unlocking novel data-based insights.

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

October 02, 2023

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Control Strategy: A Feedback-Feedforward ‘Controls Hub’ for Risk, Knowledge, and Product Lifecycle Management

September 29, 2023

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

MHRA Publishes New Guidance on International Regulatory Recognition Route

September 28, 2023

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

EC Approves Polpharma Biologics’ MS-Treating Biosimilar

September 28, 2023

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

FDA Inspections Face Overhaul

September 28, 2023

The agency will be reorganizing field force and compliance functions.

Complying with Compendial Requirements

September 28, 2023

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval

September 26, 2023

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

Sucralfate Oral Suspension Recalled Due to Microbial Contamination

September 25, 2023

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.