Microbial Contamination in ISO 5 Zones


Wells Pharmacy Network, LLC
Issued on:
Inspection Dates:
29 Aug 2016 to 13 Sep 2016
1210 SW 33rd Ave., Ocala, FL 34474
  • Jessica L Pressley
  • Meredith M Cobb

Detailed Analysis

Key Observations

  • The firm initiated process validation without an approved protocol and prior to the verification of critical process aspects such as SOPs and process parameters, indicating a systemic issue in the validation and change control processes.

Possible Root Cause :

  • Lack of an approved process validation protocol before process execution for ATNAA auto-injectors
  • Execution of process validation as an 'at-risk process' prior to verification of essential process parameters and SOPs
  • Failure to investigate and address the root cause of a failed previous validation before proceeding with another validation
  • Insufficient change control and revalidation procedures after changes to the remediation program

Corrective Action:

  • Implement a formal process validation protocol approval process before initiating validation execution.
  • Establish a requirement for completing all verifications (SOPs, process parameters, instrument calibration, and training) before executing process validation.
  • Conduct a thorough investigation to identify root causes of validation failures and document the findings before proceeding with subsequent validation efforts.
  • Develop a robust change control procedure that ensures revalidation of the process whenever there are significant changes to the remediation program.

Preventive Action

  • Enhance training for personnel involved in process validation to ensure understanding of protocol approval, execution, and documentation requirements.
  • Implement a system for real-time monitoring of process validation activities to identify and address failures or deviations promptly.
  • Establish a routine review of process validation programs to identify and implement continuous improvement opportunities.
  • Introduce a stricter oversight mechanism for change control to ensure all changes are justified, approved, and followed by appropriate revalidation.
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