Missing Conclusions and Justified Follow-Up on Discrepancies


Bioiberica, S.A.U
Issued on:
Inspection Dates:
31 Jan 2022 to 04 Feb 2022
Carrer Antic Cami de Tordera 109 - 119, Palafolls, Barcelona, 08389
  • Arsen Karapetyan

Detailed Analysis

Key Observations

  • The observation indicates a systemic issue with the firm's approach to handling unexplained discrepancies, suggesting that improvements are required not just procedurally but also in the organizational culture and understanding of quality assurance.

Possible Root Cause :

  • Inadequate extent of investigation to include all relevant batches during a campaign, suggesting a potential lack of comprehensive risk assessment and management process.
  • Limited consideration of all potential sources of contamination or process inconsistency, indicating a possible gap in problem-solving methodologies or understanding of process interdependencies.
  • Potential deficiency in training or awareness regarding the importance of thorough investigation documentation and CAPA effectiveness, demonstrating a possible organizational knowledge gap.

Corrective Action:

  • Initiate a comprehensive review of all microbiological non-conformity investigations and CAPAs for the past 12 months to ensure they are adequately extended, justified, and documented.
  • Implement a mandatory training program focused on enhanced problem-solving techniques, effective root cause analysis, and comprehensive risk assessment for all Quality Control, Manufacturing, and CAPA management staff.
  • Revise SOPs related to investigation and CAPA processes to include explicit requirements for investigation scope, documentation of rationale for conclusions, and effectiveness checks for implemented CAPAs.

Preventive Action

  • Develop and integrate a risk management framework into the quality system to ensure all potential impacts are adequately assessed and addressed during investigation and CAPA activities.
  • Establish a Quality Assurance oversight function for real-time monitoring and review of investigation adequacy and CAPA effectiveness.
  • Incorporate periodic audits of investigation and CAPA records into the internal audit schedule to ensure compliance with updated SOPs and regulatory requirements.
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