Metrics Contract Services (Metrics), Mayne Pharma Group Limited’s contract development manufacturing organization (CDMO), culminated its years of preparation for the US Drug Supply Chain Security Act (DSCSA) with two qualified commercial bottling lines for serialization.
The commercial lines are housed in the company’s $80m oral solid dose commercial manufacturing site located in Greenville, NC. The site was purchased by Mayne Pharma in 2015 and opened in April of 2018, to meet the growing demand for oral solid-dose pharmaceuticals.
Packaging capacity has doubled with the expansion of the Greenville site. One bottling line remains dedicated to clinical packaging after being updated, and two new bottling lines for commercial use have recently been qualified for serialization, including a New Jersey Machine with an IMA automated case packer and palletizer.
A spokesperson for Metrics told us that since clinical packaging is not within the current scope of DSCSA the site expansion project has allowed Metrics to dedicate an existing bottling line for clinical packaging services and continue those services without any impact.
Through its expansion, the site is able to provide both commercialization and testing, manufacturing, and packaging services.
"Qualifications were performed on the line equipment, the serialization equipment," The spokesperson further explained. "Using multiple levels of overlapping qualifications helped mitigate risk related to the qualification."
While the two bottling lines were just recently qualified, the Greenville site had been supporting more than 30 Mayne Pharma products across 90 stock-keeping units (SKUs) through the serialization transition, according to Metrics’ executive VP Kimberly McClintock’s statement in a press release.
Metrics implemented Optel systems on the packaging lines and is using TraceLink as its level four and five provider to manage network connectivity.
Both commercial packaging lines include aggregation capabilities in consideration of the next regulation enforcement deadlines.
"Aggregation, track and trace are the next anticipated regulation deadlines in 2023, which will require unit level traceability," the spokesperson told us.
DSCSA serialization and compliance
In 2017 the US Food and Drug Administration (FDA) published a draft guidance for the DSCSA, advising on what activities require licensure and annual reporting under the act, among other clarifications. The guidance also added a year to the original deadline.
The act was originally signed into US law in November 2013 as a way of providing regulations and standards to track and trace drug products throughout the supply chain.
Under this act, by November 26, 2018, wholesale distributors must only buy and sell drug products that have been serialized. As of 2020, pharmacies and hospital dispensers can only buy and sell prescription medications that display a serialized product identifier, and by 2023 all product transaction and verification data must be in an electronic format.
Metrics was unable to provide comment at this time.
