Beyond Use Dating
Advanced Pharma has developed different protocols and stability validation studies with drug and device manufacturers according to USP standards. We are able to provide extended room temperature stability that allows partner hospitals to order and stock their products without the worry of short shelve life.
End Product Testing
Every batch of products we produce must pass sterility testing to verify and validate the absence of microbiological contamination. In order to demonstrate stability and sterility of Compounded Sterile Preparations (CSP’s) for a period of time greater than that described in USP <797>, the CSP must maintain chemical and physical stability and integrity, and protection against microbiological contamination (USP<1150>). Verification of product integrity and quality may include quantitative and/or qualitative testing as well as personnel requirements (USP <1163>).
We pride ourselves on our extensive Continuous Quality Assessment and Improvement Program (CQAIP) that continues to expand. It covers many United States Pharmacopeia monograph to include:
(1) USP <71> - Sterility Tests
(2) USP <797> - Pharmaceutical Compounding – Sterile Preparations
(3) USP <1150> - Pharmaceutical Stability
(4) USP <1163> - Quality Assurance in Pharmaceutical Compounding
(5) USP <1075> - Good Compounding Practices
(6) General Notices – Preservation, Packaging, Storage, and Labeling