COMPLIANCE & TRAINING SOLUTION

PROBLEM

Pharmacies are required to comply with guidelines almost as strict as those required of pharmaceutical manufacturers. This includes standards in technique, training, and environmental concerns. The USP, ASHP, The Joint Commission, and the State Boards of Pharmacy are working to update the standards that regulate how pharmacies compound sterile preparations.

USP <797> states that a provider of Compounded Sterile Products (CSP’s) must have in place a QA Program intended to provide a mechanism for monitoring activities and processes and must demonstrate effectiveness of all procedures critical to the accuracy and purity of finished CSPs. Such testing can be very costly and time consuming.

SOLUTION

The ValiMed Regulatory Compliance Solution provides validation of your sterile preparations and documentation of your quality process to meet the USP <797> recommendations and other regulatory guidelines.