Drug Development

Chris Kilbee is group director pharma of CPhI.

Articles

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Technology and QbD Drive Pharma Development

Charles N. Kettler, PhD, is director of Natoli Scientific.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

Quality by Design—a Fundamental Paradigm Shift in Pharmaceutical Manufacturing

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Quality by Design in Contract Service Relationships

Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.

Particulate Matter Prompts Baxter's Recall of IV Solutions

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

Dissolution Problems Spur Three Recalls

Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.

Baxter Issues Recall Due to Particulate Matter

Keith Bader is senior director of technology at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Kelly Jordan is an engineer, at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.

Cleanability of Pharmaceutical Soils from Different Materials of Construction

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

BMS Recalls Coumadin Vials Due to Particulate Matter

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA Issues Warning Letter to GSK Biologicals

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

Process and Scaling