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Quality Standards

At SCA Pharma, quality is expected but never assumed. It is built into our processes and verified in our products. From the initial customer request for a new product to the release of a finish good, quality is our foundation.

continuous quality improvement

Quality in Recruitment and Training

Our people are our greatest asset, and their dedication creates an unmatched level of client service that establishes our company as the leader in our industry. SCA Pharma has dedicated recruitment staff who identify individuals with the strengths necessary to excel in this specialized industry. Next, we provide those individuals with a formalized, documented training programs and the tools they need to provide quality products to your patients.

Quality in Facilities and Process Validation

Our facilities are designed for compliance with FDA regulations, and we continuously strive to improve workflow processes. Our customers are welcome to perform audits to see firsthand how we employ quality across our facilities. All cleanrooms and equipment are validated through robust qualifications and routine calibrations. Qualification of sterile compounding personnel, processes, and facilities includes media fills which represent full-scale production batches.

Quality in Product Development

At SCA Pharmaceuticals, we constantly uphold our core value of excellence in providing specialty sterile compounded pharmaceuticals that are backed by quality, safety, integrity, accountability and outstanding service. We work with our customers to identify products that meet their needs. Product development performs extensive testing prior to production including stability testing to establish extended Beyond Use Dating (BUD) and ensuring that labeling on finished products meets all applicable standards.

Quality in Materials and Suppliers

Quality products start with quality raw materials. SCA has revamped our Vendor Qualification, Supplier Standards, and acceptance criteria for Raw Materials to be in compliance with cGMP standards.

Quality in Production and Release

Per FDA 503B regulations, compounding at SCA Pharma is performed under the supervision of licensed pharmacists who verify the critical steps in every batch produced. Finished products are then held in Quarantine until all release testing is complete.

Sterility: SCA Pharma utilizes Scan RDI (Rapid Microbiological Technology) to perform sterility testing on the final products of EVERY BATCH. This method, which has undergone a complete in-depth validation per USP <1223> for alternative methods, provides complete testing of drug product in addition to container closure. SCAN RDI provides same day sterility results.

Endotoxin: Endotoxin testing is performed on every lot produced by SCA Pharma. In-house equipment has undergone extensive validation and fulfills requirements for endotoxin (pyrogen) testing per USP <85> and cGMP guidelines.

Potency: SCA has a potency master plan that describes the required test methods, drug product specifications and a risk-based approach to implementation.

Environmental Monitoring: SCA Pharma performs comprehensive environmental monitoring performed during compounding per USP <1116> and <797>. Finished products remain in quarantine until testing results are reviewed and released by the independent Quality Unit.

Independent Quality Release: The independent Quality Unit creates and signs a Certificate of Conformance (C of C) for each batch that contains the test results compared to the product specification. Batch specific C of C’s are available to demonstrate conformance to all 503B testing requirements and the highest quality and sterility assurance possible.

Quality through Continuous Improvement

At SCA, we value continuous improvement and track progress through our Pharmaceutical Quality System. We value input from our customers and actively seek their feedback on ways to make meaningful improvements. SCA tracks and trends Product Complaints to prevent future issues.

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