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

Steps Towards Demystifying Risk-Based Decision Making

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

Computer Validation Confirms Evidence

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.

Digitalization of QbD Risk Assessments

Topic

Somnath Mishra, Somnath.mishra@shabas.net, is president at Shabas Solutions LLC.

William Hauck is senior associate at Shabas Solutions LLC.

Zachary Royal, is senior consultant at Shabas Solutions LLC.

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

Articles

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 

Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

Cheryl Barton is director of PharmaVision, 

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

Overhauling the Human Medicines Directive and Regulation 

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Health crises, political tension, and budget concerns were major challenges.

Pandemic and Politics Shaped Pharma and FDA in 2022

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records.

Frequently Asked Questions about Batch Records

High-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.

Drug Product Security

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

FDA Approves $3.5 Million Hemophilia B Gene Therapy

Robert Thomas is a member of the Inorganic Subcommittee of the ACS Reagents Chemicals Committee.

The complete online database of ACS Reagent Chemicals is now available.

ACS-Grade Reagents’ Database Launched

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

FDA Committee Recommends Ardelyx Kidney Disease Drug 

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments