Failure to Adhere to Established Process Control Procedures


Nephron Sterile Compounding Center LLC
Issued on:
Inspection Dates:
08 Nov 2022 to 10 Feb 2023
4500 12th Street Ext, West Columbia, SC 29172-3025
  • Sonya M Edmonds
  • Song Y Lavalais
  • June P Page
  • Mary-Jeanet Mcgarry
  • Jamie L Port
  • Melanie M Walker
  • Clifton L Randell

Detailed Analysis

Key Observations

  • Non-compliance with established procedures for documentation and labeling of samples, and unauthorized equipment modifications indicate a systemic issue with process control and change management.

Possible Root Cause :

  • Lack of adherence to established procedures for documentation and labeling of environmental and personnel monitoring samples.
  • Absence of real-time printer access, leading to non-contemporaneous labeling practices.
  • Incomplete or inadequate change control process management for equipment modifications and additions, leading to unauthorized or unvalidated changes.
  • Ineffective training or oversight causing staff to disregard or improperly execute written procedures.

Corrective Action:

  • Revise existing procedures to clearly define contemporaneous documentation practices.
  • Ensure real-time access to printers for immediate labeling of environmental and personnel monitoring samples or develop a validated alternate method for real-time labeling.
  • Implement a rigorous change control review process for equipment modifications, including design specifications, material of construction verification, and impact assessment on the environment and product quality.
  • Conduct retraining sessions for all staff on the importance of adhering to written procedures, documentation practices, and change control policies.

Preventive Action

  • Establish a robust training program that emphasizes the significance of following written procedures and documenting actions as performed.
  • Introduce regular audits to ensure compliance with written procedures and change control management.
  • Develop a system for real-time tracking and immediate correction of procedural deviations.
  • Strengthen the change control process with detailed guidelines for every step, from proposal to final implementation, including mandatory validation and documentation.
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