Microbiology FDA 483 (Panacea Biotec): Procedures designed to prevent microbiological contamination for are not established, written and followed (Sterile Drug)

Observation

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

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Panacea Biotec Pharma Ltd.

System

Quality System, Laboratory Controls, Facilities and Equipment System

Details

Specifically,
(A) Viewing of the aseptic filling area is only available through real time and previously recorded videos. During this inspection reviewed the last aseptic batch recorded on the same line *** Injectable Suspension, (*** mg), which uses the same procedures as product for the U.S. market, as well as previously recorded batches of *** injection, ***mg/vial, manufactured from August 28, 2022, to May 31, 2023. The following discrepancies were noted during the review of aseptic practices:
(1) Poor aseptic technique was noted during aseptic connection performed during the set-up of equipment for the aseptic filling of ***. The aseptic operator pried off the *** cover resulting in the forceps contacting the opening of the batch tank. Additionally, during the review of *** batch  ***, a second operator was observed entering the extended LAF area while the aseptic connection was taking place. Having a second person enter the area during the aseptic connection is not address in the smoke studies or media fills.
(2) An operator was observed extending the RABs *** over the running conveyer belt containing open vials during the aseptic filling of *** Injectable Suspension,*** mg filled on Sep. 24, 2023. No vials were discard.
(3) Peeling *** tape was observed being used inside the RAB/RAB for identification of the RAB ***.
(4)  An operator was seen struggling to open the (RAB *** at *** , prior to setup of filling equipment used during the aseptic filling of ***, lot *** on Feb. 5, 2023. During An aseptic operator was observed trying to “fix” the seal on the same *** at 14:31 during set-up of the equipment. This activity is not covered in set-up or any other procedure.
(5) Personnel monitoring is performed *** the ‘filling machine parts assembly — open ***”. During this activity, the operator performed aseptic connections. Prior to being monitored, the operator’s gloves are exposed to *** numerous times.
(6) The forceps used to perform interventions at the filling equipment is located directly below the RAB *** port. The operator
needs to extend his hand through the *** port prior to using the forceps to perform interventions at this location.
(7) Aseptic operators tuck the *** above the mobile LAF when unloading sterile items into the extended Grade A area. Gaps between these *** were observed during the review of  *** videos.
(B) Qualification of aseptic personnel is deficient in that it does not specify activities to be performed during a media fill in order to be qualified
(1) Although ** operator performs set-up during routine manufacturing, during a media fill, multiple operators divide up this
task. Who performs what activities is not documented. This could result in an operator who installs the stopper bowl being qualified to install the filling ***during routine manufacturing.
(2) Qualification of engineers, supervisors or IPQA personnel is not specified in BFI-PD-119 Procedure for Qualification of Person for Working in Aseptic Area (critical Operations), vs, dated 27AUG23.

Record Date

10/2023

FEI Number

3007187282

Country

India

Citation Type

483

Audit Duration (Days)

8

Investigators

Sandra A Boyd, Muna Algharibeh

More observations from same firm / company

Microbiology FDA 483 (Panacea Biotec): Deficient Aseptic processing areas for environmental monitoring conditions

Microbiology FDA 483 (Panacea Biotec): Deficient Aseptic processing areas for environmental monitoring conditions

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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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