Inadequate QCU Review of Procedure Changes


Kilitch Healthcare India Limited
Issued on:
Inspection Dates:
12 Oct 2023 to 20 Oct 2023
Kilitch Healthcare India Limited, R - 904 905 T T C Industrial Road, Navi Mumbai, Maharashtra, 400706
  • Anastasia M Shields
  • Justin A Boyd

Detailed Analysis

Key Observations

  • The failure to open a change control for the significant change in material grade from non-pharmaceutical to pharmaceutical demonstrates a systemic weakness in the firm's change management process and highlights potential risks to product quality and patient safety.

Possible Root Cause :

  • Lack of adherence to the established change control procedure, SOP KHIL/RB/QA/016/-R07.
  • Inadequate training or oversight on the importance of documenting and evaluating all changes to product components.
  • Ineffective communication between departments regarding the significance of changes to product formulations.
  • Insufficient risk assessment practices to identify and mitigate potential impacts of changes on product quality and patient safety.

Corrective Action:

  • Review and reinforce the change control procedure, ensuring all staff are trained on its importance.
  • Implement a more robust system for tracking and reviewing all changes, including supplier or material grade changes.
  • Enhance communication protocols between quality control, procurement, and other relevant departments to ensure changes are documented and assessed comprehensively.
  • Conduct a thorough review of all products that may have been affected by the change in material grade, to evaluate potential risks to patient safety.

Preventive Action

  • Develop and implement a training program focusing on the change control process and its impact on product quality.
  • Introduce regular audits of change control records to ensure compliance with procedures.
  • Establish a cross-functional review team to evaluate the significance of changes and their potential impact on product quality and patient safety.
  • Incorporate risk management practices into the change control process, including risk assessment for each change and mitigation strategies.
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