SCA Pharmaceuticals staffs a sophisticated Quality Unit fully dedicated to patient safety and excellence in sterile compounding. SCA is registered with the FDA as a 503B outsourcing facility, and the Quality Unit is committed to meeting and exceeding these guidelines, as well as Chapter <797> of the United States Pharmacopeia and all additional state and federal regulations. SCA has also contracted with a global sterile manufacturing pharmaceuticals company and utilizes their expertise in cGMP to strive for continuous quality improvement.
Two Quality Managers experienced in cGMP-based pharmaceuticals oversee a team of qualified analysts and microbiologists to ensure the safety and sterility of all compounded products. Quality controlled standardized operating procedures serve to regulate all aspects of production, with multiple checks and verification steps throughout. Every unit of medication compounded at SCA undergoes 100% visual inspection and sterility testing is performed on each batch. In addition to product testing, Quality Control maintains a robust environmental monitoring program that tracks and trends air, surface and personnel sampling in aseptic areas.
With the addition of a state of the art modular cleanroom in 2014, SCA now has two ISO 7 sterile compounding laboratories with multiple ISO 5 Laminar Air Flow Hoods. Cleanrooms are operated by a highly-skilled compounding staff of Pharmacists and Certified Pharmacy Technicians with years of experience and advanced training in high-risk sterile compounding. The Quality Unit is responsible for ensuring training and qualification compliance for all cleanroom personnel, as well as administering annual aseptic recertification and conducting periodic quality audits. In our facilities, procedures, personnel and products, quality is SCA’s highest priority.