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.

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.

The European Commission Approves Severe Alopecia Areata Treatment

September 21, 2023

Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.

EC Approves Fixed-Dose Oral Combination Treatment for AML

September 20, 2023

Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.