Lack of Bacteria and Mold Control in Manufacturing Areas

Overview

Company:
Alvotech Hf
Issued on:
22-Mar-22
Feinumber:
3013702557
Inspection Dates:
10 Mar 2022 to 17 Mar 2022
Location:
Saemundargata 15-19, Reykjavík, Iceland, 101
Investigators:
  • Madushini Dharmasena, PhD, Senior Pharmaceutical Quality Assessor
  • Yetao Jin, PhD, Chemist
  • Cynthia Jim, Consumer Safety Officer

Detailed Analysis

Key Observations

  • The manufacturing areas have experienced an unacceptably high number of mold recoveries and microbial excursions in recent years, indicating a lack of effective control over bacteria and mold. This suggests that the environmental monitoring processes, action limits, and CAPA measures currently in place are insufficient and require significant improvements.

Possible Root Cause :

  • Inadequate environmental monitoring and control measures for bacteria and mold in manufacturing areas.
  • Insufficient action limits for mold recoveries, leading to delayed or no action being taken to mitigate microbial contamination risks.
  • Ineffective CAPA measures that fail to address the root causes of microbial excursions, resulting in recurring contamination issues.

Corrective Action:

  • Revise and enforce stricter environmental monitoring protocols, including lower action limits for mold recoveries, to promptly address microbial contamination risks.
  • Implement effective cleaning and disinfection procedures specifically targeting mold and bacteria to prevent their proliferation in manufacturing areas.
  • Investigate all instances of microbial excursions thoroughly to identify and mitigate root causes, preventing future occurrences.

Preventive Action

  • Conduct a comprehensive review of current environmental monitoring strategies and improve them to ensure more effective control over bacteria and mold.
  • Enhance training for personnel on best practices for maintaining aseptic conditions in manufacturing areas.
  • Regularly audit and update CAPA procedures to ensure they are effective in addressing the root causes of microbial control issues.
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