Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination 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 Manufacturing

Firm / Company

Kilitch Healthcare India Limited

System

Facility and Equipment System, Laboratory Controls, Quality System

Details

(1) Smoke studies do not show demonstrate appropriate airflow:

(a) Smoke studies for Line *** and Line *** show turbulent and non-unidirectional airflow inside the filling ***.

(b) Smoke studies do not include set-up activities or interventions such as: opening component bags and adding sterile components; picking up fallen bottles; clearing blocked bottles, *** caps; or adjusting the *** insertion equipment.

 

(2) Your film’s Aseptic Process Simulation (Media Fill), outlined in procedure SOP KHIL/RB/QA/082, “Aseptic Process Simulation (Media Fill Validation)”, May 3, 2023, and Protocol KHIL/RB/QAP/VL/08/10-B/R01, entitled, “Aseptic Media Fill validation – ***, ***, Batch #*** failed to include interventions representing worst-case or even nominal production activities during commercial manufacturing. Numerous Interventions were observed on October 12, 13, 17 and 19, 2023. The following are examples of discrepancies found regarding the type of intervention and its duration, which were performed during the Aseptic Process Simulation Study, compared to those observed during manufacturing of commercial drug products:

  • Clearance of blockage of *** bottles & cap. *** One Time, Batch *** observed continuous clearance of blockage in the *** for 10 minutes and 15min consecutively while observing filling for *** on October 19, 2023.
  • QA person entry into the filing area. ** one time, Observed QA entering and exiting the filling room.
  • Empty vial fallen on conveyer” Operator clearing bottles fallen on the conveyer. *** One time, Observed >12 times in *** on October 19, 2023, during the filling of ***, ***, Batch #*** and >25 times between 14:10 and *** during the filling of *** on October 12, 2023.
  • Loading bottles into the bottle *** using the *** scoop. Not simulated, ***, ***, Batch *** observed scooping 96 times in 24 min of observing filling on October 19, 2023.
  • Operator wiping a spill of the *** that holds the filling *** and the surrounding conveyer belt with both hands simultaneously, using a blue non sterile cloth. Not simulated. ***, ***, Batch ***, observed numerous times while observing filling between 11:10 and *** on October 12, 2023.

Record Date

11/2023

FEI Number

3011853060

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Anastasia M Shields, Justin A Boyd

More observations from same firm / company

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-laboratory-controls-do-not-include-the-establishment-of-scientifically-sound-and-appropriate-specifications-and-test-procedures/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-procedures-are-not-established-written-and-followed-to-prevent-microbiological-contamination/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-laboratory-records-not-complete-not-assured-compliance-with-sop-standards/

 

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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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