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

Observation

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Panacea Biotec Pharma Ltd.

System

Quality System, Laboratory Controls, Facilities and Equipment System

Details

Specifically,
(A) Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Adequate scientific justification could not be provided for the following:
  1. Change control BIC 295/22, dated June 30, 2022, regarded the changing of the NVPC probes located in *** RAB *** RAB. The probes were moved to the opposite site of the *** RABs, away from operator activity and raised approximately *** higher than their previous location.
  2. Setting the non-viable particle (NVP) limits to the following:
    • ASSEMBLY OF FILLING/SEALING EQUIPMENT: Non-viable particle (NVP) excursions are not investigated, and an impact assessment is not performed unless *** excursions (minimum of *** ) or unless a minimum *** successive alarm events within ***  occurs more than *** times. Assembly of equipment takes approximately *** to ***..
    • FILLING: NVP excursions are not investigated, an impact assessment is not performed, and exposed vials are not discarded until >*** NVP monitoring excursions are obtained. BFI-PD-079 Operation of Online Particle Counter procedure states excursions ≤ *** are not investigated, and the exposed vials are not discarded. NVP excursions are only investigated and vials are discarded if the excursions exceeds *** or a minimum *** successive alarm events in ***.
    • SEALING: NVP excursions ≤ *** are not investigated, an impact assessment is not performed, and exposed vials are not discarded. Only excursions occurring more than *** times and lasting over *** (minimum of ***) or a minimum of successive alarm events in *** occurs more than *** times would trigger an investigation and discarding of the open and exposed vials. Sealing activity lasts approximately ***.

(B) Aseptic personnel working in the Grade A area are held to Grade B gowning standards when leaving the aseptic area. Although the operator performs open *** set-up of the *** RAB/RAB and stands in the Extended Grade A area throughout filling, these operators are held to grade B gowning specifications of *** CFU/Plate during their gowning personnel monitoring upon *** the aseptic area.

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): Procedures designed to prevent microbiological contamination for are not established, written and followed (Sterile Drug)

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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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Product contact equipment including *** stopper drums, *** were sterilized without outer wrapping and transferred from Grade A cart to Inside of the RABS without cover in Workshop *** Filling Room ***.

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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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