Unreviewed and Unapproved Procedure Changes


Qualgen LLC
Issued on:
Inspection Dates:
29 Apr 2021 to 15 Jun 2021
14844 Bristol Park Blvd., Edmond, OK 73013
  • Margaret M Annes
  • Preston B Hoover

Detailed Analysis

Key Observations

  • Significant changes, including the implementation of parametric release of sterile drug products and modifications to the visual inspection program, were made without documented review and approval through a formal change control process, indicating systemic issues in adherence to and enforcement of change control procedures.

Possible Root Cause :

  • Lack of established change control process for documenting and approving changes prior to implementation.
  • Inadequate training or awareness regarding the importance of documenting changes through formal change control processes.
  • Quality Control Unit may lack oversight or authority to enforce compliance with change control procedures.

Corrective Action:

  • Establish or reinforce a formal change control procedure that requires documentation and approval of all changes impacting cGMP systems, processes, methods, materials, equipment, facilities, utilities, or documents by the Quality Control Unit prior to implementation.
  • Conduct training sessions for all relevant personnel on the importance of the change control process and the steps required to comply with it.
  • Perform a retrospective review of changes made without formal change control to assess their impact on product quality and patient safety, and take necessary corrective actions.

Preventive Action

  • Implement regular audits to ensure compliance with change control procedures.
  • Enhance oversight by the Quality Control Unit to ensure that all changes are appropriately reviewed and approved according to the change control procedure.
  • Establish a tracking system for change control requests to ensure timely review and approval.
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