Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, announced successful qualification of two commercial bottling lines for serialization at its new US$80 million oral solid dose commercial manufacturing site in Greenville, North Carolina, USA. This marks the culmination of several years of preparation and investment to comply with the new requirements associated with the US Drug Supply Chain Security Act (DSCSA), which are subject to enforcement starting November 2018.
As part of the Greenville site expansion, packaging capacity has more than doubled. One bottling line is dedicated for clinical packaging, and two commercial bottling lines have been qualified for serialization. The newly installed equipment includes a New Jersey Machine with an IMA automated case packer and palletizer. The new commercial facility has space available to add a third commercial packaging line as needed to support future growth.
Mayne Pharma has implemented Optel systems on the packaging lines and is using TraceLink as its level 4 and 5 provider to manage the enterprise and network connectivity. Qualification of both commercial packaging lines includes aggregation capabilities in anticipation of the next regulation enforcement deadlines.
Metrics’ Executive Vice President Kimberly McClintock said, “We are pleased to provide serialized bottling services to our Metrics’ clients to complete our concept to commercialization offering. Our ability to offer testing, manufacturing, and packaging all at one site in North Carolina offers an efficient and convenient supply chain solution. While this is a new service offering for Metrics, the Greenville site has substantial firsthand experience supporting more than 30 Mayne Pharma products across 90 product SKUs through the serialization transition. Metrics’ clients have access to a seasoned team with direct experience ensuring successful serialization interactions with 3PLs, wholesalers and retailers.”