What Happened at Eugia?

Eugia Pharma Specialities Limited was inspected in January 2024, and received 9 observations relating to contamination risks, process records, and data integrity, among others. The inspection was conducted from 22nd Jan 2024 to 2nd Feb 2024.

According to Form 483, which was 22 pages long, the critical nature of sterility in drug manufacturing requires immediate attention to remediate the contaminants’ risks and process integrity to ensure consumer safety and compliance with FDA standards.

What were the observations made?

• Inadequate microbiological contamination procedures: Procedures to prevent microbiological contamination not established during aseptic filling operations; interventions not properly documented or executed.‍
• Incomplete laboratory records: Laboratory records missing complete data for integrity testing, environmental monitoring data was fabricated, and non-viable particle count samples were incorrectly reported.‍
• Insufficient batch production and control records: Incomplete information relating to the production and control of each batch, including documentation inaccuracies and unrecorded interventions.‍
• Validation of aseptic processes lacking: Procedures for microbiological contamination prevention did not include adequate validation of aseptic processing, with deficiencies noted in airflow visualization studies.
• ‍Unthorough discrepancy reviews Failure to thoroughly review discrepancies and failures of batches, with inadequate investigations into the root causes of contamination and defects.‍
• Lack of production and process controls: Process performance qualification studies did not evaluate intra-batch or inter-batch variability, and allowed time limits for line stoppages were not validated.‍
• Inadequate computer controls: No controls to prevent time and date changes by operators on Climet and dissolved oxygen meters, and not using available data backup functions.‍
• Unapproved changes to written procedures: Procedures regarding inspection time points and CCTV recording review were implemented without proper justification or impact assessments.‍
• Deficient laboratory test procedures: Sterility test method suitability for drug products was deficient, with inappropriate diluent usage in testing not justified nor validated.

Procedures Impacted

Environmental monitoring, Batch manufacturing, Cleaning validation, and Change control were the key procedures that were affected.

Investigator Insight

The investigators of this Form 483 were Justin A Boyd, Eileen A Liu, and Anastasia M Shields. 

Justin A Boyd meticulously examines process controls, environmental monitoring, and data integrity to ensure compliance and quality standards are met. He prioritizes robust review processes, adequate controls over systems and equipment, and thorough process validation studies. Justin has issued Form 483s to over 10 companies in last 3 years.

Eileen A Liu heavily scrutinizes documentation, training records, equipment controls, and contamination prevention procedures. She places a strong emphasis on thorough review of discrepancies, change control procedures, and laboratory controls during inspections. She has issued 7 Form 483s in since 2018.

Anastasia M Shields follows a methodical and thorough approach, paying particular attention to critical control points, compliance with regulations, and the accuracy and reliability of data and procedures. She focuses on aseptic techniques, cleaning and sporicidal agents, environmental and personnel monitoring, quality control, complaint assessment, laboratory control data, and batch production testing programs. Anastasia has issued 7 Form 483s in 2023.

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