Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Observation

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed

Facility Type

Sterile Manufacturing

Firm / Company

Eugia SEZ Private Limited

System

Facility and Equipment System

Details

Specifically,

(A) Your firm failed to follow EP4-PR-SOP-042, “Guidelines for Working in Aseptic Area” and EP4-MB-SOP-028, “Viable Monitoring Program“. The following are examples but are not intended to be a list of all times the procedures were not followed.

(1) Interventions into critical areas during aseptic manufacturing are not replicated during Aseptic Process Simulations, to assess risk and validate the performance of the interventions. For example:

Removal of stuck vials through *** No. *** at *** during manufacture of *** Injection USP ***mg, Batch No. *** the operator was observed reaching his whole arm, including the *** portion of his arm and the fabric cleanroom gown, into the Grade A filling area to remove vials and stoppers. Aseptic Process Simulation Batch No. *** replicated intervention, occurring between 3:33 PM and 3:35 PM, did not include the operator reaching to the same depth into the Grade A area, nor was the intensity of movement and duration of the intervention accurately replicated.

(2) The written procedure, EP4-MB-SOP-028, mandates that operators perform personnel monitoring after interventions into critical areas (Grade A/ISO 5, while under Grade A air supply, prior to sanitization of hands. Examples of inadequate personnel monitoring, post *** interventions during filling operations of *** Injection USP ***g, Batch No. *** on 02/19-20/2024, on *** Line *** include:

Removal of vials through *** No. *** at *** on 02/19/2024. The operator was observed reaching his whole arm, including the *** portion of his arm and the fabric cleanroom gown, into the Grade A filling area to remove vials and stoppers from the *** area. No personnel monitoring was performed.

(3) During aseptic filling of *** Injection USP ***g, batch *** February 17, 2024 on *** the following interventions were observed:

At *** one operator passed a *** spray bottle underneath the *** conveyer to another operator on the other side without either operator first sanitizing their hands or the spray bottle. At *** the same operator left the RABS *** and returned to the *** conveyer where another operator passed a *** box of wipes underneath the conveyer without either operator first sanitizing their hands or the box of wipes. At this time three was *** drug product crossing the conveyer.
From 2:57PM – 3:07PM, one operator was performing aseptic corrective interventions while placing his entire arm inside the Grade A area and did not clear the vials located directly at the *** conveyer near ***. The operator did not sanitize the area after performing the interventions and did not perform personnel monitoring on his ***as required per EB4-MB-SOP-028-02 Viable Monitoring Program. The operator did not use slow and deliberate movements while performing the interventions. The operator used quick motion to wipe the *** and *** the RABS *** much quicker than the technique used during aseptic process simulations.

(4) During aseptic filling of *** Injection ***g, Batch *** February 16, 2024, on *** the following interventions were observed:

From *** an operator was performing an aseptic corrective intervention near the ***. He was leaning into the Grade A area over *** vials and touched multiple surfaces with his *** hands. After the manipulations there was no finger plating and one *** vial where manipulations were performed was not cleared from the line.
From *** an operator *** to perform an aseptic corrective intervention of clearing fallen/stuck vials from the filling conveyer. He was leaning into the Grade A area over the filling line while performing the intervention. The operator touched the filling line tubing with his *** sleeve several times during this intervention. He also adjusted the conveyer with his *** hands and did not sanitize the same areas that were touched. The operator did not perform personnel monitoring on his *** as required per EB4-MB-SOP-02802 Viable Monitoring Program.

Record Date

03/2024

FEI Number

3011905047

Country

India

Citation Type

483

Audit Duration (Days)

Investigators

Ashar P Parikh, Marcellinus D Dordunoo

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Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.