Specialty Licensed Pharmaceutical Facility

Care. Commitment. Compassion.

Qualifications

Our professional handling of critical medications meets and exceeds established global drug distribution standards, including the revised European GDP guidelines of 7 March 2013.  We strictly adhere to our QMS, providing continuing education for all staff members.

One-World works with third-party compliance advisory organizations within the EU and the US to constantly improve our quality assurance.  Our facilities are successfully audited numerous times each year by government regulators, customers, and suppliers.

Certified and recognized by:

  • U.S. Food and Drug Administration (FDA)
  • U.S. Department of Homeland Security (DHS)
  • U.S. Transportation Security Administration (TSA)

Licenses held:

  • U.S. Drug Enforcement Agency (DEA)
  • Georgia Drugs and Narcotics Agency (GDNA)
  • Georgia Secretary of State
  • Georgia State Board of Pharmacy

Complies with:

  • U.S. Drug Supply Chain Security Act (DSCSA)
  • EU Falsified Medicines Directive (FMD)
  • U.S. Foreign Corrupt Services Act (FCPA)

Strategic Location

Headquartered in Atlanta, Georgia near one of the busiest transport hubs in the world, One-World offers multiple shipping options and services to meet the needs of any time-sensitive situation throughout the world.  Many pharmaceutical and biotech companies have offices in Atlanta and all of the major pharmaceutical distributors have major distribution centers here.

Our relationships with the leading transport companies allow us to ship worldwide while seamlessly integrating technology using:

  • Delta Cargo Equation Service
  • United Parcel Service (UPS)
  • FedEx
  • DHL
  • Marken
  • Patheon
  • World Courier
  • numerous others

Security

One-World has invested in a robust security integration platform from Honeywell International to counter the ever-growing threat of pharmaceutical theft and to assure proper product handling in our facility. The system includes:

  • Access control and smart card solutions to restrict access and manage employee movement
  • Comprehensive perimeter intrusion control and detection system with the latest video, movement and sound technology
  • Interior video system located throughout the facility including the controlled drug, refrigerated and ambient product handling areas.
  • The data collected through this integrated security system is continuously recorded and monitored allowing for remote smart phone viewing and instant notifications.

Environmental Monitoring

Pharmaceuticals and biologics are increasingly environmentally sensitive and great care must be taken when handling, storing and transporting. Innovative technologies are central to the successful management of these high-value treatments.

Our holding facility consists of three mapped chambers that maintain different temperature ranges within strict tolerances defined by US and EMA pharmacopeia guidelines. Additionally, humidity ranges are controlled electronically through a programmed humidistat. All these environmental measures are continually monitored and all the data kept on disk drives. Any chamber range deviation alarms the dedicated staff members 24 hours a day, 7 days a week and appropriate action is taken.

To maintain supply chain integrity and mitigate environmental hazards during transport, we use only validated shippers with temperature monitoring during transport. All products are shipped in innovative, thermal packing solutions.