Proper Review and Approval of GMP Change Proposals

Overview

Company:
Wockhardt Limited
Issued on:
15-Dec-15
Feinumber:
3002808500
Inspection Dates:
07 Dec 2015 to 15 Dec 2015
Location:
Wockhardt Limited Plot No 138, G.I.D.C. Industrial Estate, Bharuch, Ankleshwar, Gujarat, 393002
Investigators:
  • Daniel J Roberts

Detailed Analysis

Key Observations

  • The failure to initiate and document change controls for significant changes, such as changing testing laboratories and updating TOC instrument software, indicates a systemic weakness in the change management process. This limitation not only involves compliance risks but could also impact the quality and integrity of the drug products.

Possible Root Cause :

  • Lack of a robust change management process to document, review, and approve changes in a timely manner.
  • Insufficient training or awareness among staff regarding the importance of documenting changes and obtaining approval from quality units.
  • Inadequate oversight or verification processes to ensure compliance with change control procedures.

Corrective Action:

  • Review and strengthen the existing change management process to ensure all GMP relevant changes are properly documented, reviewed, and approved by the appropriate organizational units and the quality unit.
  • Conduct training sessions for staff on the importance of the change control process and the need to document and seek approval for all changes.
  • Implement a periodic audit process to review change control documentation and compliance to ensure adherence to procedures.

Preventive Action

  • Develop and implement a change control training program for new employees and refresher courses for existing employees to emphasize the importance of following change control procedures.
  • Introduce a change management software tool to streamline the documentation, review, and approval process, making it more efficient and traceable.
  • Enhance supervision and accountability mechanisms to ensure changes are not implemented without proper authorization.
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