Microbiological Environmental Monitoring at the Focus of an FDA Warning Letter

Why the company's answers to the deficiencies were reported insufficient
On 13 May 2020, the FDA issued a Warning Letter to the Korean company Samchundang Pharm Co, Ltd. following an inspection conducted in October 2019. In addition to the topics of "test methods", in particular the sterility test, and employee qualification, this Warning Letter focused on deficiencies in microbiological environmental monitoring. FDA Warning Letters always refer to corresponding chapters of 21 CFR Part 211.

"Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv))

What deficiencies were identified?

  • The routine identification of all isolates found in the bottling environment was not performed.
  • According to the SOP the isolates were grouped according to their morphology and only one isolate from each group was routinely used for species identification.
  • In the personnel monitoring programme there were alarm and action limits of 3 and 4 CFU/plate respectively. The FDA expects that the employees there will remain free of contamination and the limits will be adjusted accordingly. Any growth in the number of people working within the ISO 5 range should always trigger an appropriate investigation.

How did the company concerned react?

In response to the deficiencies, the company stated that it was revising its microbial identification procedures to identify all "Grade A" and "Grade B" isolates. The grouping of isolates should be refined based on area, operational status, area classification, sampling and morphology.

Why the company's answers to the deficiencies were reported insufficient

The FDA considered the answers to be insufficient. In particular, a typical observation in FDA Warning Letters, a retrospective evaluation of the deficiencies found on the quality of products already released, was missing.  For ancillary cleanrooms beyond the aseptic core area, the FDA lacked requirements for the identification of microorganisms at species or, if applicable, genus level. These identified microorganisms would also have to be entered into a database.

What further action does the FDA expect?

In response to this Warning Letter, the FDA expects a comprehensive, independent and retrospective review of personnel and environmental monitoring data since 2018, which should include the evaluation and corrective and preventive actions (CAPA) for the monitoring program (including personnel monitoring) to ensure that CAPA measures support robust aseptic filling environment monitoring. The assessment and CAPA measures, including any recommendations from an independent review, should include a justification of sampling locations, sampling frequency, alarm and action limits, adequacy of sampling techniques and trending programme.

Source: FDA Warning Letter to Samchundung Pharm Co. dated 13 May 2020

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