As a 503B Outsourcing Facility, Edge Pharma has a robust Quality Assurance team, operating independently from our manufacturing team. Edge is registered with the FDA, and is thus subject to FDA inspections and required to report a product list to the administration biannually. The Quality Assurance team, made up of pharmacists, PhD level biochemists, and quality experts, oversees rigorous testing on all of Edge’s products. We asked Kurt Radke, Edge’s Director of Quality Assurance, to discuss how Edge Pharma ensures its more than 80 pharmaceutical products achieve a specified standard of safety.
Q. First off, could you define “Quality,” as it pertains to pharmaceutical products?
A. 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.).
Q. How are the incoming materials that make up Edge’s compounded products validated?
A. 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.).
Q. What kind of training do laboratory technicians have before they work with products? Is training updated?
A. 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.
Q. What production controls are in place to ensure a product’s potency and stability?
A. 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.
Q. What kind of tests are regularly performed?
A. 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.
Q. How are customer complaints documented and investigated?
A. 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.
Q. Please explain Current Good Manufacturing Practice and how CGMP objectives inform Edge’s Quality Program.
A. 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.