Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient for monitoring environmental conditions

Observation

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

Facility Type

Sterile Manufacturing

Firm / Company

Zydus Lifesciences Ltd.

System

Details

Review of the non-viable particle count (NVPC) continuous monitoring from the ***, which is used to transport *** vials from the filling line to the *** show frequent communication errors. These occur when the unit fails to have an adequate WFI signal or power to the NVPC is lost, leaving gaps in the ability to report NVPC data. These communication errors were first documented in a maintenance notification, July 23, 2020, but no effective actions have been taken to ensure NVPC data is available continuously during batch production activities. For example, during line set-up, filling, and *** loading:

(1) For batch *** batch *** on January 19-20, 2024, there were 49 communication errors totaling 1 hours and 30 minutes of time. This included communication errors from *** on January 19, 2024, when *** vials were being loaded into the ***.

(2) For batch *** batch *** on April 7-8, 2024, there were 45 communication errors totaling 2 hours and 3 minutes of time. One communication errors lasted 41 minutes and 46 seconds.

(3) For batch *** batch *** on April 1-2, 2024, there were 54 communication errors totaling 58 minutes of time.

 

The procedure 0317-SOP-MFG-00037 requires a breakdown notification if the errors continue during the batch, but provides no specific instructions describing the threshold that would require a notification. No breakdown notification was generated for batches ***.

 

Additionally, the alarms are not being acknowledged in a timely manner with comments entered to describe the activity occurring. For example, during batch *** communication errors on April 2, 2024 at *** (8 minutes 43 seconds duration), *** (8 minute 56 seconds duration), and *** (8 minute 42 seconds duration) were not acknowledged in the system until *** on April 2, 2024. The comment was written as “NA” and did not assess the impact of the loss of NVPC data prior to loading *** vials into the ***.

Record Date

04/2024

FEI Number

3013712903

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Justin A Boyd & Anastasia M Shields

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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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