Greenville Site Has Long Track Record of Commercial Manufacturing Excellence
With additional capacity created with the opening of Mayne Pharma’s $80-million site expansion in Greenville, N.C., Metrics Contract Services is now able to offer its development clients “concept to commercialization” solutions in one contiguous location under one site registration.
But while commercial manufacturing is a new offering for Metrics clients, it’s not a new capability for our team. The Greenville site has successfully manufactured and packaged commercial products for more than 10 years now. It simply was a factor of space in our previous commercial manufacturing facility that Metrics did not offer larger-scale production more broadly to clients.
Here are some other facts about Metrics’ experience in bringing commercial products to market and supporting them through manufacturing and packaging:
- 2004 marked the first regulatory application approval referencing formulation, process, method development, manufacturing and testing by Metrics Contract Services.
- To date, 11 regulatory approvals have been issued referencing manufacturing and testing performed at the Greenville site.
- Metrics now provides laboratory support for more than 23 commercial products — and has for several years.
- Currently, 11 commercial products are being manufactured at the Greenville site; this includes tablets and capsules in immediate and modified-release formulations.
- We anticipate that an additional 8 to 10 commercial products will be manufactured at the Greenville site by the end of 2018.
Metrics also is proud of the excellent compliance track record of commercial manufacturing at the site. It includes:
- 14 successful Pre-Approval Inspections (PAIs)
- More than 30 Qualified Person (European Union) inspections
- Four consecutive FDA inspections — the most recent one in April 2017 — with no Form 483s.
- Two commercial bottling lines ready for November 2017 serialization regulatory requirements.
“Metrics confidently offers clients ‘concept to commercialization’ by employing the same quality systems, quality oversight and manufacturing expertise that has enabled more than a decade of successful commercial manufacturing with a track record of regulatory compliance,” said Kimberly McClintock, Executive Vice President.
Contact us to discuss how Metrics can help you today.