Selected Auditing Services

We were asked to perform a complete review of the stability testing program for one of our client’s flagship products.  Since this was a complete audit, we started the audit by reviewing the stability requirements and procedures established by our client. 

We reviewed their written program that established items such as sample size and testing intervals, and the range of storage conditions they were going to use for their product.  The plan also referenced the exact test methodologies to be performed and requirements for testing stability using final packaging.

Once the review of the planning documents was complete, we moved to the execution of the plan.  Our auditors observed the storage conditions, packaging specifics and the appropriateness and completeness of the test methods.  We observed the sample pulls to make sure the appropriate samples were being analyzed, and observed sample preparation and instrument analysis for the samples.  Finally, we audited the processing and reporting of the final stability results.

●  We performed an initial assessment to examine the appropriateness and completeness of the stability testing program for the main product of one of our clients.

●  The product was a binary system, which the doctor mixes in their office to generate the final product.

●  The binary system required stability testing on the unmixed syringes, as well as the constituted product prepared from the stored components.

●  As is typical, several storage conditions were used, along with accelerated conditions.  Since the product was to be stored in a doctor’s office, room temperature was the preferred method.

●   Between the different components, the constituted product and the multiple storage conditions and timepoints, our auditors observed a great number of analytical tests.  We worked very closely with the client to assure our auditors were available when the stability testing needed to be performed.