Inadequate Investigation of Discrepancies and OOS Results

Overview

Company:
Eugia Pharma Specialities Limited
Issued on:
02-Feb-24
Feinumber:
3008461619
Inspection Dates:
22 Jan 2024 to 02 Feb 2024
Location:
Eugia Pharma Specialities Limited 34 To 48 Plot No: 4, Unit - Iii; Tsiic, Sangareddy, Telangana, 502307
Investigators:
  • Justin A Boyd
  • Eileen A Liu
  • Anastasia M Shields

Detailed Analysis

Key Observations

  • The firm's failure to thoroughly review discrepancies has led to repeated issues in production, which could compromise the quality and safety of the drug products.

Possible Root Cause :

  • Inadequate investigation procedures leading to failure in identifying root causes of media fill failure, high reject rates, and out-of-specification results.
  • Failure to implement an effective Corrective and Preventive Action (CAPA) system that addresses and prevents recurrence of identified issues.
  • Insufficient monitoring and control over the filling line environment and equipment, particularly regarding vial breakage and conveyor spillage.
  • Lack of a robust stability testing program that includes hypothesis testing to verify or refute potential causes for stability failures.

Corrective Action:

  • Review and revise investigation procedures to ensure thorough and systematic analysis of all discrepancies observed during manufacturing and quality control testing.
  • Enhance the CAPA system to ensure it effectively identifies root causes, implements suitable corrective actions, and verifies their effectiveness before closure.
  • Implement stringent monitoring and control measures for the filling line to prevent vial breakage and ensure immediate cleanup and investigation of any spillage.
  • Develop a comprehensive stability testing program that includes hypothesis testing for out-of-specification results to accurately determine their cause.

Preventive Action

  • Conduct retraining for relevant staff on investigation procedures and CAPA management to ensure compliance with revised procedures.
  • Install advanced sensors or video monitoring systems to detect and address equipment failures, such as vial breakages, in real-time.
  • Conduct a risk assessment for all manufacturing processes and equipment to identify and mitigate potential failure points.
  • Establish routine review meetings to discuss the outcomes of investigations and the status of CAPAs to ensure follow-through and effectiveness.
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