Eleven observations in USFDA 483 to IPCA Ratlam

IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023 by USDA inspectors Rajiv R. Srivastava, Salim A. Akhtar, Wenzheng Zhang. The observations cites deficiencies in the manufacture and control of APIs and Intermediates – Inadequate failure investigations of OOS, Deviation, Complaints; Failure of Quality unit in taking timely actions on recall, loading reworked batches for stability, failure to report and review all deviations by third(3^rd) party consultant while certifying batches;  Failure in establishing adequate manufacturing controls and process conditions with repeat OOS incidents on an API, lacking evaluation of risk of carry over of impurity from raw material to API,inadequate cleaning frequency of equipment to prevent cross contamination. The 483 observed inadequacies in specifications and test methods with the impurity specifications in starting material lacking scientific justification, carry over studies for impurities from starting material to drug substance were not representative, absence of independent assay tests in specification for raw material and inadequate system suitability tests for raw materials. It was observed that chromatographic methods used different integration parameters within a sequence for standards and different lots of product. Deficiencies were also observed in the calibration of laboratory equipment and certification of secondary (working) standard. The 483 also observed failure to maintain complete record of equipment use and cleaning.

USFDA 483 IPCA Ratlam