PRZOOM - /newswire/ -
Raleigh, NC, United States, 2011/02/17 - Having experienced a significant increase in clients and projects, Metrics, Inc. has created a new validation manager position and appointed Reneé L. Smith to serve in it.
Smith brings nearly 10 years of validation management experience to her new role, and is especially knowledgeable about master site plan protocols for equipment, facilities, utilities and operations. Most recently, she served as senior validation associate for a large commercial manufacturing operation.
An important part of Good Manufacturing Practices (GMP), validation documents that process, procedure or method reproducibility leads to expected results – thus ensuring that the resulting products meet intended quality, safety and efficacy standards. Before Metrics created this validation manager position, an internal multi-disciplinary team oversaw the company’s validation efforts. That team will continue functioning and will now assist Smith as she centralizes oversight of validation activities.
“Validation is how a respected contract pharmaceutical development and manufacturing company like Metrics proves to clients that our work will consistently meets their requirements,” said Tom Wilson, vice president of quality operations. “Validation is something Metrics has done well since our start. Because of our sizeable growth in recent years, we felt it was time to consolidate our internal validation activities and designate one point-person to be accountable for it.”
Smith holds a master’s degree in pharmaceutical science/industrial pharmacy from Campbell University, from which she also received her bachelor’s of science degree in pharmaceutical science and biology. Her expertise includes aseptic and solid dose processes.
Metrics Inc. (metricsinc.com) is one of the most respected contract pharmaceutical development and manufacturing companies in the United States today. Started as an analytical laboratory in 1994, Metrics has evolved into a full-service provider of quality pharmaceutical formulation development; first-time-in-man (FTIM) formulations; clinical material manufacturing (CTM) for Phase I, II and III trials; commercial manufacturing; and analytical method development and validation services.
Headquartered in Greenville, N.C., Metrics has particular expertise in FTIM and Phase I, II, and III CTM manufacturing. The company has conducted more than 120 FTIM projects for different chemical entities in the last five years alone – while developing more than 700 batches of CTM in the same period.