FDA 483 - GPT Pharmaceuticals Private Ltd - June 28, 2019

GPT Pharmaceuticals Pvt. Ltd. underwent an FDA inspection from June 24-28, 2019, revealing significant deviations from current Good Manufacturing Practices (cGMP) for a drug product manufacturer. The regulatory framework necessitates adherence to cGMP to ensure drug product quality, safety, and efficacy.

The inspection identified critical deficiencies across multiple systems. The Quality System was deemed ineffective, failing to thoroughly investigate unexplained discrepancies and Out-of-Specification (OOS) results. Investigations were often superficial, relying on retesting without robust root cause analysis. Documentation practices were severely lacking, with instances of original samples discarded, incomplete OOS investigations, backdated records, and critical testing activities not accurately or contemporaneously recorded. Electronic data integrity was compromised by uncontrolled spreadsheets, inconsistent chromatogram headers, and unauthorized changes to HPLC columns. Furthermore, Quality Assurance lacked adequate oversight on Quality Control data review. Controls over computer systems were poor, with no clear procedures for user privileges or chromatographic peak integration, and numerous unexplained 'delete' and 'abort' entries in audit trails.

Product expiration dates were unsupported by adequate real-time stability data, and previous studies were scientifically deficient. Employee training was insufficient, particularly for tasks like critical sample collection. Production processes lacked proper validation, and master and batch production records were incomplete, failing to accurately reflect actual manufacturing operations. Lastly, equipment cleaning procedures were ineffective, with manufacturing equipment observed to be visibly dirty despite being signed off as 'cleaned,' and cleaning validation protocols lacking scientific justification for sampling methods and hold times. GPT Pharmaceuticals Pvt. Ltd. is required to implement comprehensive corrective actions to address these systemic issues and achieve cGMP compliance.