Following an FDA inspection, a large global pharmaceutical company was cited for a number of non-compliance issues at a manufacturing facility producing a bulk active pharmaceutical ingredient (API). When the issues were not resolved in a timely manner, the FDA issued a warning letter and directed the discontinuance of production until the deficiencies were corrected, inspected and approved. The facility remained closed for more than two years, costing the company more than $300 million per year in lost revenue and corrective actions. After the production plant was substantially modified, and all facilities, equipment and processes needed to be re-certified in time to meet the supplemental new drug application (sNDA) deadline.

As time was of the essence, Praxis struck the proper balance between accelerated work and the due diligence required by regulations. We worked with the project team to methodically review, analyze and summarize all validation and qualification studies for the manufacturing facility. The project scope included:

• Facility infrastructure
• Manufacturing equipment
• Manufacturing processes
• Computer control systems

After completing the detailed validation review and remediation, Praxis helped to write and submit the review findings in the form of Validation Summaries in the sNDA.

Given the complex nature of the project and the short timeline (only three months to the submission deadline after Praxis was engaged), the company's senior management did not expect to meet the deadlines that had been set for submitting the sNDA. Much to their pleasure and surprise, the sNDA was submitted on schedule. Upon subsequent FDA inspection, the manufacturing facility was found to have no non-compliance issues. The facility was approved and production was back online, literally saving the company millions of dollars and restoring the product revenue stream.