Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Observation

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product

Facility Type

Non-Sterile Manufacturing

Firm / Company

Sun Pharmaceutical Industries Limited

System

Details

Specifically,

(A) On 04-Dec-2023, observed about 450 mL of *** “stagnant liquid” partially covered in sections with *** layers inside the Air Purification Unit (APU) in between the *** filter and the *** of Processing Area *** ID: GPN/EQ/285. Your firm stated the accumulation of stagnant liquid may have occurred after the last preventative maintenance of 13-Oct-2023 due to leakage of water from the *** located inside *** close to the APU. This area gets verified for cleanliness during the *** preventative maintenance. There is a potential for the growth of microorganism in the stagnant liquid in the area where the temperature is ***°C to ***°C while is use for *** and at around ***°C while not in use.

The filtered air from the ***µ filter flows through the section containing stagnant water at a high velocity (*** m/sec *** )) into the *** Unit and the ***. There is a potential for microorganisms, yeast and mold growth in this stagnant liquid that could potentially contaminate via the high velocity air the material under *** in *** ID: GPN/EQ/285.

Per my request on 04-Dec-2023, your firm collected a sample of this stagnant liquid for microbial and chemical analyses. The microbial analyses revealed TNTC (Too Numerous To Count) microbial, yeast and mold colonies. There is a potential for microorganisms, yeast and mold grown in this stagnant liquid to get carried with the high velocity air through the *** into the *** ID: GPN/EQ/285 and potentially contaminate the product while it is used for manufacturing drug products.

The chemical analyses by LC-MS showed the presence of *** API along with numerous large areas of peaks pertaining to *** and *** impurities. There have been about *** different drug products manufactured since the manufacturing of product containing *** API (last manufactured on 16-Sep-2023) using *** ID: GPN/EQ/285.

Based on these observed chemical and microbial test results, there is a potential for contamination of *** drug products that are manufactured using this non-dedicated *** ID: GPN/EQ/285 for the US market.

 

(B) On 04-Dec-2023, I observed a hole and rough around the *** located inside the body of *** ID: GPN/EQ/285. I also observed light yellowish color sealant that was used to cover gaps surrounding the *** was missing sealant and small pieces of *** on the hole. There is a potential for these missing pieces may have mixed into the products manufactured using this nondedicated ***. Further, there is a potential for the deposition of powdery materials to get accumulated inside the holes and rough surfaces which may not get removed during the manual Type B (product changeover) cleaning of this equipment. According to your procedure (SOP No.: SOP009109, Version No.: 10.0), there is no swab sample collected and tested for chemical and microbial testing from these areas *** ID: GPN/EQ/285.

Record Date

04/2024

FEI Number

3004561553

Country

India

Citation Type

483

Audit Duration (Days)

10

Investigators

Pratik s Upadhyay

More observations from same firm / company

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

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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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