FDA 483 - Lupin Manufacturing Solutions Limited - January 17, 2020

This FDA Form 483 document details observations from an inspection, highlighting deficiencies in critical process parameter control, discrepancy investigations, secondary reference standard management, and raw material sampling.

**Facility and Operation Details:** The document refers to the production of intermediates and Active Pharmaceutical Ingredients (API), including exhibit batches and process performance qualification (PPQ) studies.

**Violations and Observations:**

* **Process Validation Deficiencies:** * Failure to identify critical process parameters (CPPs) during PPQ studies. For example, "Quantity of" was identified as a CPP, while other parameters crucial for chemical reactions were deemed non-critical in PPQ protocols/reports (PVP/MPP1/065/00, PVR/MPP1/063/00, PVR/MPP1/068/00). * Failure to perform hold time studies during critical processes and production steps. Hold time studies were only conducted after all chemical reactions were complete. * **Discrepancy Investigation Failure:** The firm failed to thoroughly review unexplained discrepancies, even for distributed batches. Specifically, during exhibit batch production and PPQ studies, discrepancies were not investigated in a timely manner. Instead, a change control was initiated to revise product limits for API (e.g., exhibit batch results for batch #, batch #, and batch # showed varying results). * **Secondary Reference Standard Deficiencies:**