Medical Device Manufacturing Facility – Quality System Enhancement/FDA Response

The Challenge

A Fortune 500 Class 2 – Medical Device Manufacturer had received an FDA warning letter and was seeking assistance to correct the identified observations.

The Solution

Performance Validation (PV) provided a dedicated team of specialists in Production and Process Controls, Process Validation, Computer System Validation, Cleaning Validation, Laboratory Equipment, and Methods Validation to work with the client.  The work was broken into the following phases:

• Phase I Audit and Assessment
  • Our team audited the client’s existing validation program and identified variances from the Quality System Regulation and standard industry practices as identified by GHTF, USP, ICH, GAMP and ISPE.
• Phase II Enhancement
  • Based on the number of variances identified, a consensus decision was reached to develop a new enhanced validation program rather than revising the existing program.  The program consisted of procedures and templates that addressed the following attributes:
    • Validation – top level procedure that tied all elements of the validation program together.
    • Subordinate procedures and templates for the  qualification and validation of:
    • Facilities/Utilities
    • Production Equipment
    • Laboratory Equipment
    • Computer Systems
    • Test Methods
    • Cleaning Methods
    •  Processes
• Phase III Training
  • On approval of the enhanced Validation Program, PV assisted in the development and execution of the training modules which addressed each procedure, template, and intended use of the system.
  • PV assisted in providing validation program training to the Production Design, Manufacturing, and Quality elements of the organization over a 6 week period.
• Phase IV Implementation
  • PV assisted the implementation of the enhanced Validation program by  providing:
    • Validation support to assist the client in development of all required validation deliverables
    • Implementation of a validation consultant group (personnel with greater than 10 years of validation experience) as a temporary measure to set strategy, and assist in the pre and post execution review of validation documents.  This team provided insight and guidance to the validation engineers authoring documents and the management team approving the documents.
• Phase V Maintenance of the System
  • Transfer of knowledge from the contract resources to client personnel and the internalization of the validation department using client resources.

The Results/ Benefits

• The enhanced validation program was successfully implemented.
•  Additional weak links in the quality/production systems were identified and corrected which increased the robustness of the manufacturing process and the quality system.
• Transfer of knowledge from contract provided resources to the client was completed with the client establishing an internal dedicated validation group.
• The enhanced validation program successfully completed internal and external corporate audits.
• The system was evaluated by the FDA in two separate inspections which resulted in the facilities regulatory status changing from Official Action Indicated  to Voluntary Action Indicated to its current status of No Action Indicated.

For additional information, please schedule a call with one of our subject matter experts.

Brad Henry
Vice President, Indiana Division Director
Performance Validation