Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

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.

In Equal Measures: The Importance of Excipient Quality

September 03, 2023

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

The Future is the Present: Artificial Intelligence in Pharmaceutical Manufacturing

September 03, 2023

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

September 03, 2023

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Improving Manufacturing Flexibility with Modules

September 03, 2023

Modular facilities allow for a certain amount of flexibility and reconfiguration options.

Preserving Process Integrity: The Importance of Equipment Cleaning

September 03, 2023

A structured cleaning procedure is essential to ensure the effective cleaning of equipment.

Accelerating Clinical Trials in the EU

September 02, 2023

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Clinical Trials and their Impact on the Pharma Industry

September 02, 2023

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Clearing Up Confusion in Inspection Terminology

September 02, 2023

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

White House Sets Medicare Price Negotiation Targets

August 31, 2023

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

FDA Approves Bristol Myers Squibb Anemia Treatment

August 31, 2023

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.