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

Observation

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Panacea Biotec Pharma Ltd.

System

Quality System, Laboratory Controls, Facilities and Equipment System

Details

Specifically,

(A) Smoke studies are inadequate in that they do not demonstrate unidirectional air flow in the following instances:

(1) The “smoke” is not always positioned above the intervention taking place.

(2) The camera angles and distance from activity is not appropriate to thoroughly evaluate the air flow patterns during interventions.

(3) The firm tucks the *** above the mobile LAF when unloading sterile items into the extended Grade A area. A smoke study was not performed to show that this activity does not allow Grade B air to enter the extended Grade A area.

 

(B) Media Fills are not representative of routine production.

(1) During the review of approximately 2 hours of filling activities for *** for Injectable Suspension, ***mg, lot ***, ***, excursions into the ** RABs unit, using the RAB ***, were not document for:

    • Adjustment of the tubing around the filler.
    • Extension of the operator’s arm into a RAB ***. The operator did not perform an intervention.

(2) RAB *** interventions performed in *** RAB***, (loading of the ***) are not documented. This would include picking up fallen vials or wiping up a spill.

(3) PB1/M1/PR019-00 Va1idation Protocol for *** of ***RAB/RAB with***. Disinfectant Solution Report, dated May 14, 2022, was discrepant in that:

(a) The location of the *** was not documented during execution of this protocol. The location specified in the Annexure-3 of this protocol for RAB *** is not feasibly possible as a partition is at that location.

(b) The location of the BIs is not based the hardest to reach locations. There is no risk assessment performed for the location of the Bls.

(c) BFI -PD-075 Operation and Cleaning of ***RAB/RAB procedure states to “ensure that the ***RAB and RAB*** are exposed manually or with the help of *** towards ***, for complete disinfection “. It is unknown which activity took place during the validation as this condition is not documented. If manual exposure was executed, the duration and how the manual exposure was performed was not documented.

(4) The firm does not trend interventions for individual batches.

(a) A summary of interventions is performed ***. This summary only specifies the batches which have the highest frequency for each specific intervention. The trending of individual number and type of interventions occurring for each batch, to support this summary, is not retained.

(b) Only the previous ***’ worth of data is used in determining the number of interventions to perform in a media fill. This can result in the number of interventions performed during a media fill being less than the number of interventions seen in batches for the previous year.

(c) Run speed, length of filling and hold time prior to filling is not tracked. These activities are represented in the media fill.

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

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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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