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Compounding

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.

 

Category Leiter's
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