CASE STUDY: Developing Custom Test Methods to Generate Data for the Risk Assessment of the OTC Manufacturing Process and Set Batch Release Criteria
The Challenge
Eurofins accepted a request to perform testing compliant with 21 CFR Parts 210/211 on an excipient material for over-the-counter pharmaceutical products and develop specific test methods to support the risk assessment of the manufacturing process and batch release. The test results for the product at the initial stability time point were within specifications. However, several test results were out-of-specification (OOS) at the three-month stability time point.
Our Approach
The required testing for this material extended across a broad spectrum of capabilities, test methods, and instrumentation, including HPLC-RI, GC-FID, IR Spectroscopy, UV Spectroscopy, Polarimetry, ICP-MS, Karl Fischer Moisture Analyzer, Water Activity Meter, Muffle Furnace. Eurofins worked closely with the client to perform the feasibility of several test methods on the product before beginning validation. In addition, Eurofins developed a specific test method to test for elemental impurities that could be introduced to the product by the manufacturing line. The test development proved challenging due to the client's requirement for a method with a low detection limit and high sensitivity.
The OOS results prompted immediate action, with both organizations collaborating on the best path forward, including designing experiments where Eurofins performed priority turnaround analysis of lab R&D samples as the client tried the different proposed variables.
The Solution
Ultimately, we found that the bags used to contain the material were at fault. An added benefit of the initial method development work was the reduced sample volume required for analyses compared to the initial estimates. The reduced sample size enabled the errant results to be detected early at the 3-month interval.
While this was an unfortunate setback to the client's original timeline, it greatly benefited the client's development team in facilitating the needed conversations with their corporate stakeholders to make the necessary adjustments and changes in the future. The close partnership between Eurofins and the client resulted in a fully validated method that generated the data required for the manufacturing processes' risk assessment and batch release certificate of analysis.
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