Method Suitability testing for USP <71>, Sterility Testing
This process evaluates your product against control organisms to ensure that no inhibition/enhancement occurs during the testing process. Controls are listed by USP, and the incubational process is approximately 5 days for the recovery. Two incubational temperatures and media are used for this process. Although USP only requires one lot for traditional compounding to meet this process, we highly recommend three lots if the compounder is producing in bulk, or shipping across state lines. This is completely your call. Sampling from three lots can occur over time, allowing for concurrent release testing of the product as long as sampling is according to USP <71>.
Method Verification for USP <85> Bacterial Endotoxin Testing
This process requires the screening of your compounded product for inhibition/enhancement effects. Again, USP only requires one lot for traditional compounding to meet this process, but we highly recommend an individual sample from three lots if the compounder is producing in bulk, or shipping across state lines Currently, we are completing this process by Gel Clot Methods according to USP<85>.
Method Verification/Validation for Potency Testing
USP provides two chapters for guidance on this issue. USP <1225> and USP <1226>. If we use the method directly from USP, only verification is required for the analysis of your product. If we use an alternative, or in-house method we must complete the validation phase of this testing for your product. We already have a majority of our in-house methods validated and ready to go. Your product would be verified against in-house validated methods.
Please remember we do have a non-validation/suitability option for testing compounded products available if preferred. These testing methods are carried out according to compendia procedures but do not include the method suitability/verification/validation steps. Data is reported according to an internal SOP reference rather than USP <71> or USP<85>.