After receiving an FDA Warning Letter, a well-known pharmaceutical company requested from Synergy to get involved in the remediation of their warning letter. Part of the warning letter remediation efforts was related to several thousands of product manufacturing Batch Records reviews. We started the work by verifying the calibration records, NCRs/Deviations, OOS investigations, and the in-process data. Based on our review process, we presented our conclusions and recommendations to the executive management. Our recommendations were instrumental in highlighting the need to establish a mechanism to separate between their R&D and the QC laboratory activities and building a new and separate R&D laboratory, as this lied at the heart of the root cause behind the warning letter. Our success in this project was a factor in having the management extend the scope of the project for Synergy.
In the second phase of the project, Synergy team of chemists, scientists, and a regulatory compliance specialist performed Analytical Method Transfer Gap Assessment for 137 analytical methods. The outcome of the gap assessment was a determination that the methods were not properly validated according to approved protocols or compendial specifications. So, Synergy embarked on a collaborative effort to optimize these test methods using chromatographic and spectrometric techniques, by writing and executing the validation protocols for those methods that don’t have a proof of validation documentation. These analytical methods included HPLC, LC-MS/MS, GC, GC-MS, ICP-MS, TOC, among many others. Writing the validation protocols, Work Instructions, executing the validation and transferring these test methods to the QC laboratories took 3 years.
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