Microbiology FDA 483 (Panacea Biotec): Equipment used is not of appropriate design and suitably located

Observation

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Panacea Biotec Pharma Ltd.

System

Quality System, Laboratory Controls, Facilities and Equipment System

Details

Specifically, inside the aseptic area used in the manufacture of *** Injection, ***mg/vial, a box (approximately ****), is outlined on the floor of the aseptic area with a **** paint to mark the placement of the product transfer vessel. This marking is located in both the extended Grade A and Grade B area, directly outside of the ***RAB/RAB unit. The paint was observed to be flaking off and, in some locations, completely missing. The repainting of this marking last took place February 3, 2022.

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)

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

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

Microbiology FDA 483 (Panacea Biotec): Failure to thoroughly review any unexplained discrepancy to meet any of its specifications

Microbiology FDA 483 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

Microbiology FDA 483 (Panacea Biotec): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications & standards

Microbiology FDA 483 (Panacea Biotec): Responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

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FDA 483 relevant to Microbiology

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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