Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Observation

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process

Facility Type

Sterile Manufacturing

Firm / Company

Eugia Pharma Specialities Limited

System

Details

(1) In commercial production, sterile *** API is aseptically filled into canisters, approximately *** batch. *** filling, *** canister is opened and manually sampled by inserting a sampling tool in a *** LAF. This repetitive manually intensive aseptic intervention for *** canister is only included in *** media fill ***.
The filled ***API canisters are later aseptically dispensed into a ***. The *** product is filled into approximately *** canisters *** batch. *** canister is opened and manually sampled by inserting a sampling tool in a *** LAF. This repetitive manually intensive aseptic intervention for *** canister is only included in *** media fill ***.

 

(2) Airflow visualization (smoke studies) of Grade A laminar flow do not demonstrate there is appropriate air flow during commercial operations:

(a) During aseptic filling of *** bulk *** a *** laminar airflow unit with *** flow is placed *** to the *** filling area with a *** laminar flow. Open sterile cannisters are placed near *** areas. Smoke study evaluations have not thoroughly evaluated this boundary to evaluate any turbulent flow caused by the interaction of the *** laminar flow units.

(b) The manual opening and aseptic sampling of canisters in a *** LAF has not been evaluated during smoke studies. This sampling occurs *** filling bulk *** API and again *** filling the ***.

(c) The smoke studies for the areas where filling of API into canisters and for filling of *** bulk *** into canisters occurs was not configured the same way as it is used during commercial production. The smoke studies only included *** canisters, while *** were typically present in commercial manufacturing. Additionally, a sample *** and scale are present in commercial production, but not in the smoke studies. The *** supply is placed on a *** in the smoke studies, but was observed to be kept on the *** LAF during commercial batches.

(d) Your airflow visualization study conducted on the *** Line used to fill *** Protocol # E2-MIS-VSP-0073, effective June 13, 2023, performed under dynamic conditions, was not representative of commercial production for intervention C3 , “Adjustment of fill weight” (C-13 in the smoke study protocol). During our review of commercial production for US batch *** and ROW batches *** an operator was observed performing this intervention multiple times where they used the RABs *** and reached their entire arm across the filling line to manually manipulate and adjust the fill weight and ***. In your smoke study, this intervention was performed using forceps, in lieu of the operator’s arm, to reach across the line and simulate this intervention. Your media fill study conducted in November 2023 per protocol E2-***-APSP-0001, shows this same intervention, C-3, being performed through the RABs *** using a small tool, where the operator has minimal contact with the ***.

Record Date

05/2024

FEI Number

3009883410

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Anastasia M Shields, Justin A Boyd, Vaishali J Patel

More observations from same firm / company

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed

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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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