The goal of a sterile compounding pharmacy and its personnel must be to achieve a State of Control where the compounding pharmacy and compounding personnel operate under such conditions to achieve a state of microbial control.
A State of Control is achieved when:
Particle generation and contamination are kept to a minimum,
Environmental testing of Primary Engineering Control(s) and controlled areas are performed by qualified individuals,
Action limits are in place to detect excursions from this control, and
A Quality Assurance Program is implemented to ensure the clear definition, application and verification of all activities affecting the quality of the final product.
Sterile Compounding Lab Design
State of Control advises clients on both new builds and renovations of existing sterile compounding pharmacies to ensure the facility requirements are met. State of Control maintains a strategic partnership with a local multi trade company to ensure that all facility requirements (HVAC, electrical, plumbing, mechanical) are met.
State of Control evaluates current processes, facility and personnel metrics, to identify gaps in compliance with the NAPRA Model Standards. Based on this analysis, clients are provided with an Action Plan to close these gaps and meet compliance requirements.
Standard Operating Procedures
State of Control creates customized Standard Operating Procedures that address personnel, facility, compounding, and quality assurance policies and procedures.
Third Party Evaluation
Through direct observation, State of Control provides an independent, arms-length, yearly evaluation of the sterile compounding supervisor’s competencies to ensure compliance with NAPRA Model Standards.
Certification and Verification Documents
Certification documents of the Primary Engineering Control(s) and controlled areas are analyzed by State of Control to ensure compliance with the application guideline.
State of Control reviews dynamic airflow visualization studies of the PEC and clean-room, more commonly known as smoke pattern testing. Following testing, clients receive a high-quality video for training purposes and inspection.
Licensed Dealer Application
State of Control reduces the time and cost of application by facilitating the Licensed Dealer Application process with Health Canada