Edge's Quality lab and QC team are an integral part of the process. A combination of state-of-the-art equipment, testing logs, and full-time staff scientists ensure that every batch of medication delivered is both correct and safe.
Regarding Current Good Manufacturing Practices (CGMP), the FDA states, "A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work." "Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step."
Edge Pharma adheres to the values put forth by USP 795, 797, 800, and CGMP. Through this our customers have the confidence in us to deliver medications they can feel comfortable administering, whether in a doctor's office or an operating room.
Located in Colchester, Vermont, Edge Pharma is equipped with a system that monitors environmental controls and exceeds international standards for temperature, humidity, and sterility. Our facility is compliant with the following state, local, and federal regulations and guidelines:
- USP 795, USP 797, USP 800
- Occupational Safety and Health Administration (OSHA)
- Food and Drug Administration (FDA)
- US Pharmacopeia (USP)
- Applicable Good Manufacturing Practice (GMP) Guidelines
Experience and Training
With over 20 years experience as a business owner, licensed Pharmacist and Board Certified Nuclear Pharmacist William Chatoff R.Ph., BCNP has the knowledge, know-how and technical expertise necessary to deliver a superior product and service. Each member of our staff undergoes rigorous training through skills certification, competency evaluations, and on-going education for QA, QC, Product Testing, Validation Testing, and Environmental Monitoring.
- Secure delivery and quarantine room layout and access
- Strict personnel gowning practices
- Precise sterile work preparation procedures
- Facility meets or exceeds USP 795, 797, 800, and applicable CGMP standards.
Reliability and Service
Our facility is readily accessible for inspection and production monitoring by hospital, surgery center, and clinic customers. Customized formulation, delivery system, and labeling goes beyond standards to respond to the needs of your institution. Fast turnaround reduces drug shortages and eliminates the need to stockpile high-value drug inventories.