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.

Changes Afoot in Pharmaceutical Laws and Regulations in Spain

April 02, 2023

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

The Relationship Between CAPAs and Data: What’s the Right Balance?

April 02, 2023

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Legislative Hold-Up

April 02, 2023

A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.

FDA Approves Evkeeza for Young Children with Ultra-Rare Form of High Cholesterol

March 31, 2023

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda Gets Approval in Japan for Entyvio Subcutaneous Injection

March 30, 2023

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Setting Sustainability Goals with Pierre Luzeau (DCAT 2023)

March 30, 2023

Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.

US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case

March 30, 2023

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

FDA Approves First Over-the-Counter Naloxone Nasal Spray

March 29, 2023

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

Feds to Review March-In Authority on Drug Patents

March 24, 2023

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

Never Mind the Statistics; Just Tell Me What the Answer Is!

March 20, 2023

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.