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.
Credentials
Aphena's personnel, equipment and facilities are guided by exacting processes and procedures. Aphena's facilities are FDA registered and 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 - August 2011 TN facility
- FDA inspection – August 2011 KY facilities
- FDA inspection – September 2012 NJ facility
- FDA inspection – January 2012 MD facility
- DEA-licensed locations (CII-CV)
- Tennessee, Kentucky, New Jersey and Maryland Board of Pharmacy licenses
- VAWD accredited – TN facility
- ANVISA certified - MD facility
- ISO 13485-2003 & ISO 9001:2008 (BSI) registered – MD facility
- Successful UL-STR audits for KY and NJ facilities
- 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
Quality Systems
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