Change Control Procedures Not Followed


Allergy Laboratories, Inc.
Issued on:
Inspection Dates:
16 Apr 2013 to 26 Apr 2013
1005 S.W. Second Street, Oklahoma City, OK 73109
  • Paula A Trost
  • Mihaly S Ligmond

Detailed Analysis

Key Observations

  • The negligence in following the firm’s change control program indicates a systemic issue that could affect product quality, safety, and regulatory compliance.
  • Failure to validate new systems such as the Building Management System poses risks to maintaining controlled environments necessary for product stability and safety.

Possible Root Cause :

  • Lack of adherence to internal SOPs for Change Control.
  • Insufficient oversight of Facility and Equipment changes.
  • Inadequate validation procedures for new systems.

Corrective Action:

  • Revise and enforce SOPs related to Change Control to ensure all facility and equipment changes are documented and approved through Change Control Protocols.
  • Conduct training for relevant staff on the importance of following change control procedures.
  • Perform retrospective review of all recent facility and equipment changes to ensure they are documented, approved, and validated as per SOPs.
  • Validate the Building Management System as per regulatory standards.

Preventive Action

  • Implement a tracking system to monitor the initiation, approval, and completion of change controls.
  • Enhance the change control review process to include cross-functional team assessments for potential impact on product quality and compliance.
  • Conduct regular audits to ensure adherence to change control SOPs.
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