Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed

Observation

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

Facility Type

Sterile Manufacturing

Firm / Company

Eugia Steriles Private Limited

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

(A) On April 2, 2024 during post production manual cleaning of line *** RABS ID PR***RABS-001 used in the manufacture of *** injection USP ***%*** mg/mL) *** mL ***vial) batch *** the employee performing the cleaning was observed cleaning the *** conveyor and other filling station surfaces located at the *** of the ***RABS prior to cleaning surfaces located at the *** such as ***. Upon further review document EPS-PR-SOP-043-00-Procedure for Operation and Cleaning of *** Restricted Access Barrier System in Line *** Make: *** section 4.2.24 does not include Instructions for operators to perform cleaning the *** following a *** approach, and it does not include instructions for cleaning the ***.

 

(B) Per your summary report for disinfectant efficacy validation performed under protocol ES-GENP-101 approved on January 28, 2024, your firm only tested the effectiveness of *** on *** RABS *** the effectiveness of *** sporicidal agent) on this surface was not verified. A review of document EPS-PR-SOP-023 *** Procedure for Operation, Cleaning, and Changeover of *** Ampoule/vial Filling and Stoppering Machine in line *** make: *** show that disinfectant *** is used to clean these surfaces with a contact time of NLT ***. Effectiveness of the disinfectant solutions was also not evaluated on material noted as *** which is the material for the *** holding in place the *** RABS ***.

 

(C) On April l, 2024 during the line clearance of filling line *** for of *** injection USP ***%***mg/mL) ***mL *** vial) batch *** the employee performing the line clearance did not document one bottle of *** spray not working and the out of calibration status of *** RABS-PR***RABS-001 *** ES-PR-***(location filling zone) *** and ES-PR-*** (Location filling zone ***). In addition, the employee also did not verify the sterilized equipment (forceps, tubes, *** etc.) and stoppers held in *** laminar airflow chambers were within the established hold time.

 

(D) During review of your *** sterilization cycle performance qualification studies noted that the biological indicators lot *** manufacturer’s COA states a maximum incubation time of *** at *** °C however your incubation time for these BIs was ***. Per the manufacture’s recommendation if incubation was to be extended beyond *** precautions such as *** *** ***. However these precautions were not provided during your incubations only provide continuous monitoring information associated with the temperature conditions and not *** conditions.

 

(E) Production employees noted that they must climb inside the sterilization chamber without shoes or shoe covers to perform manual cleaning of the inside of the chamber.

 

(F) *** time and conditions to remove *** present on the *** of *** sterilized *** injection USP ***%*** mg/mL *** vial) have not been established. During the manufacture of batch *** residue was observed to be present on vials on April 3rd during visual inspection, the vials were offloaded from the *** sterilization chamber on April 2, 2024.

 

(G) Corrective actions enacted in response to EM/OOL/001/23 289CFU obtain from environmental monitoring settle plate located in grade C area inside change room for filling line *** did not have effectiveness to check that the corrective actions were adequate.

 

(H) Environmental contact plates used to *** of **** after filling of *** injection USP *** % *** mg/mL) *** mL *** vial) batch *** do not appear to have made contact with the surface of the ***. In addition there are no instructions for minimum contact time with the *** plate for this type of surface monitoring.

Record Date

04/2024

FEI Number

3027357163

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Teresa I Navas

More observations from same firm / company

Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes

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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.

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Alarm 1 Aseptic Behavior 30 Aseptic Technique 49 Autoclave 1 Biological Indicator 1 Building Maintenance 6 Calibration 1 Clean Room 15 Clean Room Practices 36 Cleaning and Sanitization 29 Cleaning Validation 1 Computerized System 4 Contamination 13 Contemporaneous Verification 1 Data Integrity Issue 10 Disinfectant Efficacy 2 Disinfection 15 Drug Product 1 Endotoxin 1 Environment monitoring 16 Equipment Cleaning 6 Equipment Operation 13 Facilities And Equipment System 13 Facility Design 5 Follow-Up Findings 2 General Cleaning 3 Good documentation Practices 4 Gowning 3 HEPA 4 Hold Time Study 2 HVAC 6 Influx of lesser quality air 1 Investigation 12 Investigation inadequate 5 Investigation incomplete 3 Laboratory Controls 17 Laboratory Practice 16 Maintenance 10 Manufacturing control 9 Media Fill 15 Method Transfer 2 Method Validation 5 Microbial Identification 1 Microbiological Contaminationn 10 No Procedure followed 14 Non-Conformance 1 OOS 5 Personnel Monitoring 3 Procedure 32 Qualification 32 Quality System 33 Risk assessment 6 Service Vendor Audit 1 Smoke studies 14 Specifications 5 Stability Study 2 Sterile Drug Products 5 Sterility Testing 1 sterilizati 2 Sterilization 3 Suitability 1 test procedure 0 Test Procedure (SOP) 10 Trends 1 Usage log 1 Validation 37 Visual Inspection 1 Warehouse 2 Water System 1

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