Microbiology FDA 483 (Samsung Biologics): Written production and process control procedures are not followed, established. or are deficient

Observation

Written production and process control procedures are not followed, established, or are deficient

Facility Type

Sterile Manufacturing

Firm / Company

Samsung Biologics Co. Ltd.

System

Quality System, Facility and Equipment System, Laboratory Controls

Details

Specifically,

(A) On 25 August 2023, observed for plant *** RABS Fill Line *** Batch #*** was the transition of the *** stopper bowl from Grade B space into the Grade A RABS, Furthermore, observed was the transition of a *** system from Grade B space to the Grade A RABS. where the *** bag was opened in Glade B space, with the *** bag transitioning into the Grade A RABS. In both fill line setup activities, a portion of the *** bag entered the RABS Grade A space. On 30 August 2023, a similar observation was made during a review of the Fill Line *** RABS smoke pattern video under GENP-02057. Observed was the opening of the *** bagged stopper bowl in Grade B space, with the *** bag transitioning to the RABS Grade A space that included a majority of the *** bag. SOP-MFE-00293, “Operation and Maintenance of *** Drug Product Vial Fill Machine”, v40.0, Effective date 29 August 2023 fails to provide adequate instruction for transition of *** bagged sterilized equipment from Grade B space to the Grade A RABS, where the *** bag should remain in Grade B space. You indicated that the smoke pattern video is reviewed and approved by quality, with the video used for training of fill line operators for proper RABS setup, aseptic technique.

 

(B) Video recordings of media fill runs are not always retained. Procedure: SOP-MFP-00164, “Process Simulation for Drug Product” version: 37, Effective Date: 28-JuIy.2023, states all personnel involved in aseptic operations will review excerpts of media till video with Quality and Operations management and that any poor aseptic technique identified are discussed and provided remedial training to rectify poor aseptic technique. The videos for media fills dated 22-June-2021 (batch *** and 23-June-2021 (batch ***) are no longer kept by the firm and arc not available for viewing.

 

(C) Your procedure, MET-0018, “Quantitation of Viable Microorganisms by Contact Plates”, Effective Date 07/08/2023, version 43.0 Section 8.2. I .9 states “For personnel gloves monitoring, using Finger Dab Method Aseptically open the contact plate and place his/her fingers with the glove gently on the media surface of’ one (1) contact plate (dabbing four (4) finger pads on *** and then rolling motion of thumb ensuring the entire pad of the thumb touches the surface of the media)”. On 23-Aug-2023, observed two of your aseptic operators fail to follow your procedure for fingertip personnel monitoring, Operators were observed testing the tips of their fingers instead of their finger pads during the aseptic filling of sterile injectable drug product, *** lot ***.

 

(D) On 24 August 2023, observed was the *** substance fill process, batch *** into *** Liter bottles by closed filling system, According to SOP-MFP-00074, “Inspection of Process Equipment and Materials”. v22, Effective date 08 August 2023, Section 8.1 includes visually inspect materials. probes. parts. and assemblies before use or installation and verify that it is integral and free of debris, surface anomalies, foreign residue. or defects. Observed was no visual inspection of the drug substance container closure systems for absence of defect or debris within each bottle that could have an impact on product quality, with the standard operating procedure not followed. There is no documentation requirement for the drug substance container closure system visual inspection.

 

(F) On 24-Aug-2023. observed within Building *** Drug Substance Fill *** Grade C space and gowning *** was a *** respectively, with the top surface observed in an unclean condition. SOP-MFP-00012, “Room Cleaning and Sanitization Procedure”, v84.0, Section 6.10 and 6.10.1 includes each department responsible for the cleanroom such as manufacturing (e.g., DS, DP *** Dispensing, Sampling MDF) must clean and sanitize inner / outer surfaces. including the top and rear of ******. EM carts and tools in the clean room. Difficult to reach areas that includes but is not limited to the top and rear side of control panels, *** bottom of *** etc, may include step stool/step ladder for cleaning and sanitizing high areas such as the top *** or ***. You failed to follow the procedure.

Record Date

10/2023

FEI Number

3010479596

Country

South Korea

Citation Type

483

Audit Duration (Days)

11

Investigators

Joanne E King

More observations from same firm / company

Microbiology FDA 483 (Samsung Biologics): Controls over manufacturing operations and process have not been adequately established

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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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