Neglected Investigations of Unexplained Batch Issues


Aurobindo Pharma Limited, Unit XI
Issued on:
Inspection Dates:
25 Jul 2022 to 02 Aug 2022
Aurobindo Pharma Limited, Unit XI 61 - 66 Survey No., Pydibhimavaram, Andhra Pradesh, 532409, India
  • Guerlain Ulysse
  • Jeffrey P Raimondi

Detailed Analysis

Key Observations

  • Significant number of equipment errors and a lack of holistic investigation suggest systemic issues in laboratory operations and complaints handling process.

Possible Root Cause :

  • Lack of an effective process for holistic investigation and corrective action plan for recurrent equipment errors.
  • Inadequate investigation procedures for market complaints potentially related to API quality.

Corrective Action:

  • Develop and implement a comprehensive procedure for investigating, trending, and addressing recurrent equipment errors.
  • Revise market complaint investigation procedures to ensure comprehensive evaluation of potential product quality impact, including review of API batch retention samples.

Preventive Action

  • Train laboratory staff on the new investigation and corrective action procedures.
  • Establish a robust system for monitoring and trending equipment performance and errors.
  • Review and update equipment maintenance and calibration schedules based on trend analysis.
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