Pii Announces Serialization Implementation and Readiness
HUNT VALLEY, Md., Oct. 1, 2018 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, announces implementation and readiness of their Serialization and Aggregation process to support current as well as future commercial production operations, ahead of the deadlines outlined by the FDA and in the DSCSA. Pii has successfully serialized, aggregated and shipped multiple lots of various products. All required products will be fully serialized and aggregated prior to the November 2018 deadline for serialization.
Thanks to the identification of a flexible track and trace system, our implementation allows for application to cartons and bottles for all dosage forms including tablets, soft and hard gelatin capsules, powders, and injectable products. Additionally, our track and trace solution allows aggregation to the case pack, shipper and pallet levels thus providing Pii with the capability to cater to a worldwide pharmaceutical industry. Each serialized packaging line will be capable of all aggregation configurations.
Michael Bogda, President and COO, states "We wanted to implement a system that is accurate, efficient, versatile, cost-effective and of the appropriate capacity and size to fit our production efforts. As a CDMO, our customers' needs are very diverse across a wide range of product types and packaging configurations. Being able to accommodate efficient line clearance and changeovers and still meet the various levels of customer requirements required that our team find a solution that is designed for flexibility and operational functionality. We far exceeded that expectation. Pii is now positioned to be ahead of the regulatory requirements for serialization and aggregation and we are ready to provide this key service to our customers."
About Pharmaceutics International, Inc.
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances. For more information, please visit www.pharm-int.com.
Contact:
Syed E. Abidi, Ph.D., Chairman and CEO
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
Phone: (410) 584-0001
Email: [email protected]
SOURCE Pharmaceutics International, Inc.
Related Links
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article