Inadequate Drafting and Approval of Procedures

Overview

Company:
FARMAKEIO OUTSOURCING LLC
Issued on:
14-Jun-22
Feinumber:
3014982757
Inspection Dates:
01 Jun 2022 to 10 Jun 2022
Location:
920 S Kimball Ave Ste 100, Southlake, TX 76092-9019
Investigators:
  • Patty P Kaewussdangkul
  • Steven A Brettler

Detailed Analysis

Key Observations

  • The observation indicates systemic issues in the process of drafting, reviewing, and approving documentation changes, affecting product quality and compliance.

Possible Root Cause :

  • Lack of oversight by the Quality Unit in reviewing documentation process.
  • Inadequate document and change control procedures to ensure changes are reviewed and approved.
  • Potential gaps in training regarding the importance of document control and adherence to established procedures.

Corrective Action:

  • Review and revamp the current document and change control procedures to include strict measures for drafting, reviewing, and approving all procedure changes.
  • Conduct a comprehensive training session for all relevant personnel on the updated document and change control procedures.
  • Perform a retrospective review of all changes made to procedures within the past year to ensure they were properly documented, reviewed, and approved.

Preventive Action

  • Implement regular audits to ensure compliance with the document and change control procedures.
  • Establish a continuous training program on documentation compliance for new hires and ongoing refresher courses for existing staff.
  • Enhance oversight by the Quality Unit to enforce adherence to documentation and change control standards.
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