As part of their cGMP facility operation readiness, a client of ours requested that we develop and validate a cleaning validation program to support their development and manufacturing activities of drug products that are in their late development stages. Using the Design of Experiment (DOE), we started by developing a master validation plan for sterilized processes (aseptic processing). After that, we developed the cleaning validation process map, the characterization of the residuals of drug products. Then, we performed the recovery studies and authored the cleaning process SOP and the validation protocols, followed by providing training to the client’s technical staff on how to ensure successful completion of the protocols. Then, we monitored their performance while executing the protocols to ensure compliance with the established procedures. Using Synergy’s in-house state of the art analytical capabilities, we performed the TOC analysis of the collected samples, analyzed and tabulated the results of rinse and swab sampling, and then wrote the summary report of the cleaning validation study, so it can be included in the CMC section of the drug filing applications. From start to finish, the project took only 4 months. This is a record time to complete a project of this nature in such a short amount of time. It is also a clear testimony that relying on professionals who have the expertise and the technical know-how can save you time and money and protect your business from regulatory noncompliance risk.
Ready to Write Your Own Success Story?
The results you just read about are not one-offs; they are the standard we deliver. Discover what Synergy Bioscience can do for you. Fill out the form below, and our team will reach out to discuss how we can bring the same level of expertise and results to your next project.