Unwritten and Unfollowed QCU Procedures


Alkem Laboratories Limited
Issued on:
Inspection Dates:
19 Mar 2024 to 27 Mar 2024
Khasra No 1544, 1553, 1558, 1559, Village Thana Tehsil Nalagarh, Baddi, Himachal Pradesh, 173205
  • Nicole E Knowlton
  • Yvins Dezan

Detailed Analysis

Key Observations

  • The observation highlights deficiencies in written procedures for the Quality Control Unit, inadequacies in performing required shipping studies for finished products, and inefficiencies in managing change controls, pointing towards systemic issues in documentation, compliance, and software limitations.

Possible Root Cause :

  • Lack of written procedures for Quality Control Unit responsibilities.
  • Inadequate shipping studies performed for finished products shipped to US markets.
  • Inefficiency in managing and closing change controls within specified timeframes.
  • Limitations in the TrackWise software preventing extension requests for change control records.

Corrective Action:

  • Develop and implement comprehensive written procedures outlining responsibilities and tasks for the Quality Control Unit.
  • Perform shipping studies for all finished products shipped to US markets as required by relevant protocols.
  • Review and amend change management procedures to ensure change controls are managed and closed within target completion dates.
  • Upgrade or modify the TrackWise software to allow for extension requests for change control records or implement a manual tracking system to manage these extensions.

Preventive Action

  • Conduct training for the Quality Control Unit on newly developed written procedures to ensure compliance and understanding.
  • Introduce a regular review process for shipping studies to ensure all finished products are covered and studies are conducted as per protocols.
  • Implement a tracking system for change controls to monitor progress and completion dates, ensuring timely closure.
  • Regularly review and update the TrackWise software or any system used for change management to accommodate necessary features for efficient operation.
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