During a recent FDA inspection of a compounding pharmacy, several serious GMP deficiencies were found in the facility intended to produce sterile products.
The FDA investigators identified several violations, which put patients at risk. The violations included the preparation, packing, and holding of drug products under unsanitary conditions, resulting in potential contamination. The specific violations noted during the inspection were as follows:
1. Failure to take appropriate corrective action after microbial contamination was found in the ISO 5 aseptic processing area.
2. Use of a laminar airflow hood containing difficult-to-clean, particle-generating, and visibly dirty equipment or surfaces.
3. Use of non-sterile pads and wipers within the ISO 5 aseptic processing area.
4. Use of non-sterile tools on the inner surface of containers or closures for sterile drug products.
5. Placing gloved hands outside the ISO 5 work area without sanitizing them before re-entry.
6. Inadequate segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination of hazardous drugs.
7. Failure to perform media fills under the most challenging conditions, resulting in a lack of assurance of aseptic production capability.
8. Inadequate smoke studies to demonstrate unidirectional airflow within the ISO 5 area, compromising the protection against contamination.
The FDA highlighted deficiencies in the corrective actions provided by the company, including the lack of supporting documentation, incomplete addressing of repeat observations, and inadequate measures to prevent cross-contamination and assess root causes of contamination.
The FDA recommended that the company conduct a comprehensive assessment of its operations, involving facility design, procedures, personnel, processes, maintenance, materials, and systems, specifically focusing on aseptic processing operations.
The FDA also advised the company to engage a third-party consultant with relevant sterile drug manufacturing expertise to assist in this evaluation.
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