Leiter's is registered with the U.S. Food and Drug Administration (FDA) as a 503B Outsourcing Facility under the Drug Quality and Security Act (DQSA). The 503B registration requires outsourcing facilities to comply with FDA regulations, cGMP manufacturing safety standards and routine inspection by the U.S. FDA.
All Outsourcing Facilities must comply with Current Good Manufacturing Practices (cGMPs). cGMPs are a series of strict, detailed guidelines that must be followed during the preparation of compounded medications.
Under these requirements, a representative sample of each medication batch must be tested for sterility and additional Quality Attributes, as applicable. Leiter's focus on quality systems includes extensive training, qualification of personnel, qualification of processing, personnel monitoring, environmental monitoring, sterilization verification, and finished product testing.
|Airflow Pattern Visualization||✔ Completed smoke study|
|Stability Testing||✔ Stability testing|
|Sterility Testing||✔ Sterility Testing|
|Cleaning||✔ Daily cleaning prior to production|
|Equipment Validation||✔ Validation includes IQ, OQ, and PQ|
|Aseptic Process Simulation||✔ Media fills performed in triplicate|
|In-Process Non- Viable Particle Counts||✔ Real-time particle count software|
|In-process EM/PM Monitoring||✔ In-process EM/PM monitoring|
|Sterile Gowning||✔ Specific gowning procedures for sterile cleanroom|
|Autonomous Quality Unit||✔ Quality Assurance department|
|Independent QA Batch Release||✔ Batch release performed by pharmacist|