Microbiology FDA 483 (Aurobindo/Eugia Pharma) : Batch production and control records do not include complete information

Observation

Batch production and control records do not include complete information relating to the production and control of each batch

Facility Type

Sterile Manufacturing

Firm / Company

Eugia Pharma Specialities Limited

System

Quality System, Facility and Equipment System

Details

(1) Production personnel used the “Check List for Verification of Product Contact Parts for Line *** to document the *** stopper *** bowl (IVFSM-OOI/SO***) and the cap *** bow (IVCPM-001/S0***) were removed, washed, and *** before being used in the Grade A *** for the aseptic filling of *** Injection batches *** and *** Injection batch *** (all U.S. batches). Review of CCTV showed the stopper bowl and cap bowl were not removed from the *** during the disassembling step. Production personnel confirmed they had not performed the bowl disassembly, washing, or sterilization between these batches.

(2) Per SOP EP3-PR-SOP-0***, Block *** Line *** are cleaned *** of filling activity. The e-log cleaning records document specific times the *** were cleaned for *** of the aseptically filled batches *** and *** and ***. Review of CCTV recordings showed none of the *** were cleaned. Production personnel confirmed they did not clean any of the *** Grade A associated with these batches.

(3) E-log cleaning records documented cleaning activities including mopping disinfection, *** rinse, and sanitization for the Block *** Line *** vial filling & stoppering machine (PN-IVFSM-***), and vial sealing machine PN-IVCPM-*** . Review of CCTV recordings associated with aseptically filled batches *** and *** showed most of these cleaning activities were not performed. Production personnel confirmed they did not follow the cleaning SOP for Line *** cleaning and they made up the time spent for each cleaning activity documented in the e-log.

(4) Review of the intervention records showed production personnel did not document all interventions or document interventions accurately. Production personnel inside the aseptic filling room do not have records. Intervention records are supposed to be documented by a production operator located outside of the production room continuously watching live activities from the CCTV camera. Production operators stated they may stop watching to perform weight checks or to take bathroom breaks, with no alternative person recording while they are not present. Review of recordings identified the following batches had interventions that were not recorded:

(a) *** batch *** (US market). There were 24 interventions not recorded. This included *** interventions that would have required a product non-conformance investigation. *** is the maximum permitted times for intervention (C11), clearing of jammed *** stoppers. The intervention record only documents *** occurrences, but the intervention occurred approximately 13 more times that were not documented. This would have exceeded the permitted number of interventions and required a product non-conformance investigation.

(b) *** Injectable Suspension *** Vial batch *** (US Market) had 21 interventions that were not recorded. This included six instances of clearing of jammed vials with *** PN-GP0***, which is a new intervention that would require a product non-conformance investigation.

(c) *** Injection *** mg/mL batch *** and batch *** (US market) had total 97 interventions not recorded in filling and *** record.

(d) *** Injection USP *** mg/vial, batches *** and *** (US market), had total of 167 interventions not recorded in filling and *** record.

(e) *** Injection USP *** mg/vial, batches *** and *** (US market), had total of 12 interventions not recorded

(f) *** Injection batch *** (US market) had 7 interventions that were not recorded.

Record Date

02/2024

FEI Number

3008461619

Country

India

Citation Type

483

Audit Duration (Days)

9

Investigators

Justin A Boyd, Eileen A Liu, & Anastasia M Shields

More observations from same firm / company

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-aurobindo-eugia-pharma-procedures-not-established-followed-to-prevent-microbiological-contamination-of-sterile-drug-products/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-eugia-pharma-laboratory-records-do-not-include-complete-data-data-integrity-issues/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-aurobindo-eugia-pharma-no-adequate-validation-of-the-aseptic-process-to-prevent-microbiological-contamination/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-aurobindo-eugia-pharma-investigation-failed-to-thoroughly-assess-any-other-potential-sources-of-the-microbial-contamination/

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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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Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

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