Quality Systems

Thomas S. Chirkot Ph.D, P.E., is a near-infrared sales specialist at ThermoFisher Scientific, 4410 Lottsford Vista Road, Lanham, MD 20706, tel. 570.909.7657.

Articles

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PAT

Angie Drakulich was editorial director of Pharmaceutical Technology.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Building a Framework for Quality by Design

Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD -Aegis Whitepaper

Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.

FDA's Dr. Srinivasan Discusses Question-based Reviews for Generic Drugs

FDA leaders explain the purpose and plan for ICH's three quality guidelines.

Inside ICH: Quality Trio Takes Final Shape

Warren Charlton is a consultant at WHC Bio Pharma Technical Services, PO Box 20309, Greenville, NC 27858, tel. 252.327.4733, fax 252.756.4733.

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

Applying Quality by Design to Sterile Manufacturing Processes

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

A Pharmaceutical Technology survey examines capacity expansions, outsourcing practices, innovation levels, and the role of quality by design in sterile manufacturing and aseptic processing.

Trend Analysis for Sterile Manufacturing

Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research.

Stimulus Bill Opens Door to Comparative Effectiveness

Justin Neway, PhD, is executive vice-president and chief science officer at Aegis Analytical Corporation.

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.