Quality, Purity, Honesty
Quality assurance at Hybrid Pharma is based upon the United States Pharmacopeia and Current Good Manufacturing Practices (cGMP) regulations 21CFR 211
Our experience with cGMP focused processes as well as carefully designed facilities, equipment, training and testing provides confidence to our customers in the quality of our services.
Sterility and Stability testing of Finished Medications:
Hybrid Pharma’s Quality Control testing assures the quality of all finished medications.
Finished drug products undergo extensive quality testing for strength, quality, and purity. We utilize both in-house and outsourced laboratories for analytical testing. Our testing lab is equipped with state of the art analytical equipment including HPLC, UV Spectrophotometer, Osmometer and other equipment to ensure the highest quality and purity standards for our customers and consumers.
Sterility and biological endotoxin testing are performed by either USP protocols or in house validated protocols.
The director of our analytical laboratory is responsible for developing the standards and procedures which are followed by all laboratory staff under Good Laboratory Practice [cGLP]
Hybrid Pharma works to exceed all USP and GMP standards:
USP <797> requires Viable particle air sampling testing and recertification every 6 months, Hybrid Pharma performs viable particle air-sampling every 3 months.
Facility Design and Certifications:
USP <797> Hybrid’s state of the art clean room facilities meet or exceed federal and state requirements. Our facility is certified every 6 months by an independent licensed testing laboratory as per CETA guidelines.
USP <797> requires media fill testing semi-annually for high-risk level compounding. Hybrid Pharma fulfills this requirement regularly by each pharmacist and all technicians as per protocol.
USP <797> requires environmental non-viable particle testing and recertification every 6 months. Other than certification, Hybrid Pharma monitors the environmental non-viable particle counts in-house as well.
USP <797> requires environmental viable microorganism particle sampling and recertification every 6 months. Hybrid Pharma certifies its facility as well maintains the specifications by frequent viable air sampling.