Unreviewed Discrepancies and Batch Failures


SCA Pharmaceuticals, LLC
Issued on:
Inspection Dates:
18 Sep 2023 to 20 Oct 2023
755 Rainbow Rd Ste B, Windsor, CT 06095-1024
  • Jonah S Ufferfilge
  • John P Mistler

Detailed Analysis

Key Observations

  • The SOP for handling discrepancies permits bypassing thorough investigations based on retest outcomes, leading to potential release and distribution of product without adequate assurance of sterility.
  • Inadequate investigation and documentation practices potentially compromise product quality and patient safety due to unaddressed sterility failures.
  • Lack of immediate and effective remediation actions for controlling and preventing sterility issues indicate systemic flaws in quality control and aseptic processing.
  • Insufficient awareness and control measures against spore-forming microbial contamination suggest a gap in understanding or applying sterility assurance principles.
  • Planned CAPA completion dates extending into the future without interim controls for known issues, such as spore contamination, pose ongoing risks to sterility assurance.

Possible Root Cause :

  • The procedure for handling discrepancies does not require investigation after certain test method failures.
  • Inadequate investigation procedures and oversight leading to release of product without thorough evaluation for sterility and particle count issues.
  • Lack of operational controls and monitoring for addressing and documenting sterility failures including spore-forming microbial contamination.
  • Inadequate remediation actions for sterility failure results possibly indicating systemic issues with aseptic technique and material sanitization.

Corrective Action:

  • Revise SOPs to ensure all discrepancies and failures, especially for sterility tests, require thorough investigation, documentation, and appropriate disposition decision.
  • Implement comprehensive training for relevant personnel on revised procedures and emphasize the importance of adhering to sterility assurance controls.
  • Enhance environmental monitoring in production areas especially focusing on the adequacy to detect spore-forming microbes and include remediation actions considering identified gaps.
  • Review and evaluate the effectiveness of the sporicidal disinfectants and sanitization procedures especially the contact time for totes before entering the sterile area.

Preventive Action

  • Establish routine reassessment of the effectiveness of CAPA actions related to sterility assurance to detect recurrent or systemic issues.
  • Enhance quality oversight during production, especially of aseptic processing, to ensure adherence to best aseptic practices and immediate corrective action if deviations occur.
  • Implement a robust validation process for new or revised procedures before implementation to ensure they are adequate to prevent microbial contamination.
  • Increase frequency and comprehensiveness of environmental monitoring to better identify and control sources of contamination, paying close attention to spore-forming microbes.
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