Avella operates a state-of-the-art Outsourcing Facility in order to maintain Current Good Manufacturing Processes and ensure the highest levels of quality and patient safety.
In 2013, the Drug Quality and Security Act established the designation of registered Outsourcing Facilities for large-scale, sterile compounding pharmacies. Outsourcing Facilities are subject to additional government oversight and must implement strict manufacturing standards. These standards, called Current Good Manufacturing Practices (cGMPs), are designed to ensure the quality and safety of compounded medications.
In line with our commitment to maintaining the highest levels of quality in everything we do, Avella became one of the first compounding pharmacies to register as an Outsourcing Facility. To comply with federal requirements set forth in the DQSA, Avella is proud to announce a new, separate cGMP Outsourcing Facility.
While Avella has always maintained compliance with industry standards for quality, including U.S. Pharmacopeial Convention or USP 797 standards, this facility allows us to implement even more advanced processes for ensuring the sterility, purity and integrity of our products.
Avella’s 503B Outsourcing facility and staff comply with cGMP standards including:
- Full sterile garb compliant with cGMP regulations
- Continuous environmental monitoring of air, cleanroom surfaces and personnel
- USP 71 compliant sterility testing on each batch of product; USP 85 compliant endotoxin testing on each batch of injections; GMP compliant stability studies on each product
- Advanced processes designed to ensure that every formulation conforms to high standards for identity, strength, quality, and purity
- Cleaning and sterilization protocols
This new clean room represents yet another area where Avella is leading the industry in innovation.