Unclear SOPs for Deviation and Complaint Handling Extensions


Alvotech Hf
Issued on:
Inspection Dates:
10 Mar 2022 to 17 Mar 2022
Saemundargata 15-19, Reykjavík, Iceland, 101
  • Madushini Dharmasena, PhD, Senior Pharmaceutical Quality Assessor
  • Yetao Jin, PhD, Chemist
  • Cynthia Jim, Consumer Safety Officer

Detailed Analysis

Key Observations

  • The lack of clarity in SOPs regarding the handling of extensions for deviation, complaints, and OOS, OOT, and OOE result handling processes can lead to inconsistent practices and potential compliance risks.

Possible Root Cause :

  • Lack of specificity in SOP development leading to ambiguous extension periods for deviation, complaints, and result handling processes.
  • Inadequate SOP review process that failed to identify and correct gaps in procedural instructions regarding extension periods.
  • Insufficient training or understanding of the importance of clearly defined procedures for handling extensions in deviation, complaint handling, and out-of-specification (OOS, OOT, OOE) result processes.

Corrective Action:

  • Review and revise the relevant SOPs to include specific guidance on the duration of each extension period and the maximum number of extensions allowed for deviation handling, product quality complaints, and handling of OOS, OOT, and OOE results.
  • Conduct retraining sessions for staff involved in SOP development to emphasize the importance of clear and detailed procedural instructions.
  • Implement a more rigorous SOP review and approval process to ensure all necessary details, including extension periods and limits, are adequately addressed.

Preventive Action

  • Establish a standard operating procedure for the creation and review of SOPs that ensures all procedures include detailed, clear, and complete guidance on handling extensions for deviations, complaints, and OOS, OOT, and OOE results.
  • Integrate periodic training and refreshers for staff on the importance of clarity and detail in SOP documentation, focusing on the management of extension periods.
  • Implement a continuous improvement process for SOP management that regularly reviews, updates, and improves SOPs based on operational feedback and compliance requirements.
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