Aphena's quality systems approach begins with senior leadership reporting directly to the CEO.
This commitment to compliance with both current Good Manufacturing Practice and customer requirements ensures a proactive approach. The leadership system provides a mechanism for organizational learning and process control. All associates are empowered change agents. They are knowledgeable and trusted high performers.
All operations are supervised by full-time quality control specialists and undergo rigorous validation and safety checks. All production runs are in compliance with cGMP and other FDA regulations.
Aphena's personnel, equipment and facilities are guided by exacting processes and procedures. Aphena's facilities are all FDA registered. The Tennessee site is DEA and State Board of Pharmacy licensed. The FDA's current Good Manufacturing Practice (cGMP) governs standard operating procedures. The organization meets and exceeds FDA standards for 21 CFR, Parts 210 and 211, 21 CFR 820, and 21 CFR 111.
- FDA registered / FDA inspected / cGMP compliant
- FDA inspection - Nov 2013 TN Facility
- FDA inspection – July 2013 MD Facility
- DEA-licensed locations (CII-CV)
- Tennessee Board of Pharmacy licenses
- VAWD accredited – TN facility
- ISO 13485-2003 & ISO 9001:2008 (BSI) registered – MD facility
- EDI (Electric Data Interchange) ready
- ePedigree software in place
- Serializing and in-house printing of 2D bar codes
- Wholesale and distribution licensed in more than 16 states