Quality Assurance and Control
When it comes to pharmaceutical products, quality is not just the most important thing – quality is everything.
At Edge Pharma we are committed to ensuring that our products are manufactured in compliance with all State and Federal regulations, USP, and Good Manufacturing Practice standards. Edge’s multi-pronged approach to quality includes Quality Assurance and Quality Control departments who oversee state of the art chemistry and microbiology labs. Our environmental controls meet or exceed international pharmaceutical manufacturing standards for temperature, humidity, and sterility. We follow precise sterile work preparation procedures and enforce strict personnel gowning rules.
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 feel comfortable administering, whether in a physician’s office or an operating room.
Modern equipment, full time staff scientists, and rigorous testing combine to enable us to provide customers products that are safe, consistent, and effective.
– Quality in its simplest form is “Suitability for Use.” For pharmaceutical products, FDA has defined pharmaceutical product Quality as having the correct safety profile, identity, strength, purity, and general Quality attributes (appearance, labeling, instructions for use, etc.).
– Incoming materials (including active pharmaceutical ingredients) are inspected and validation tested against their accompanying Certificate Of Analysis (COA) from the manufacturer and/or against established compendium standards (United States Pharmacopeia (USP), etc.).
– Laboratory Technicians must be fully qualified through formal education and experience before they are permitted to work with products. This includes on the job training provided by Edge and continuing education to maintain a necessary skill set. Training is updated on a regular basis to keep up with process changes and the state of the art for laboratory instrumentation operation and maintenance.
– There are two main production controls that protect a compounded medication’s Quality: Environmental (facility cleaning, clean room air pressure, microbiological and particle counts) and Batch/Analytical Testing Records (meticulous record keeping to assure that all equipment and manufacturing/testing steps are followed exactly as defined). Only after the batch/environmental record is approved by Edge Quality Assurance is the compounded medication released for sale.
– There are various tests performed during the compounding process, depending on the product. Products are inspected for endotoxin, visible and subvisible particles, pH levels, and other qualities. Before they are released for sale, sterile products are tested for sterility and potency; nonsterile products are tested for potency and bioburden.
– Customer complaints are handled according to Edge SOP “Customer Complaint Handling and Adverse Events Reporting.” Product complaints may be received from various sources including clinics, hospital pharmacies, patients, and State and Federal regulatory bodies. All complaints are investigated and processed by a Quality Assurance Pharmacist. Each complaint is categorized as a minor, standard, serious, or critical complaint. All relevant information about the complaint is captured in the record including resolution, follow up, and preventive measures taken.
– Current Good Manufacturing Practices (CGMPs) provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to CGMPs is accomplished by requiring that manufacturers of medications adequately control manufacturing operations. Edge’s Quality program has been designed with CGMPs in mind. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.