Client Size:

Global Medium Sized Company

Industry:

Pharmaceutical / Clinical Trials Supply

Project Timeline:

90 days + ad-hoc hours after submission

Business Challenge:

A Regulatory Compliance Associates client needed strategy and support with Pharma Licensing and Packaging & Labeling for a new greenfield facility.

 

Client Challenge

• An existing pharmaceutical client specializing in clinical trials supply was looking to launch a new packaging facility. The manufacturing operations team needed support with development plans and regulatory compliance.
  • Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
    • Pharmaceutical packaging
    • Labelling in pharmacy
    • Pharmaceutical bottle
    • Packaging for tablets

RCA Approach

• Scope of work included two staff augmentation resources to begin the project. 
  • The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
    • The Quality Specialist became a valued liaison while operating across departments inside the organization
      • Risk management tools were implemented in the following departments
        • Sterilization
        • Design Control
        • Validation
        • IT
        • Training employees.
  • The second resource was a Quality Subject Matter Expert with executive experience.
    • This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
      • All types of medicine packaging
        • Pharmaceutical packaging technology
          • Pharmaceutical filling
          • Pharmaceutical packaging solutions
        • Drug packaging types
          • Pharmaceutical primary packaging
          • Pharmaceutical secondary packaging
          • Pharmaceutical cold chain packaging
          • Plastic pharmaceutical packaging
        • Pharmaceutical labeling process
          • Pharma label
          • Pharma containers
          • Drug carton
          • Sustainable pharmaceutical packaging
        • Pharmaceutical packaging machinery
          • Blister packaging pharmacy
          • Unit dose packaging pharmacy

They also provide technical input and guidance from the perspective of many disciplines. After the implementation done by our Quality Specialist, this SME did the final validation of the plan and worked with the client on a “as needed” bases helping with any regulatory compliance issues.

Results

• RCA’s Quality Specialist worked collaboratively with the clients’ teams to valitate all training and SOP development. Enhancements for the new packaging facility included.
  • Design Control team was trained extensively on risk management in packaging.
  • Technology team improved their manufacturing automation through functionality that recognized the difference between “Printed Text Error” and “Packaging Component” deviations.
    • This helped isolate the number of errors to a specific step in the package leaflet process. 
• Assisted in identifying any gaps and/or opportunities with the firm’s plan.
  • Supported with any FDA authority enquiries and other global scenarios impacting the firm’s US Operations.
  • Implemented the secondary packaging and labelling protocols to match current licensing and marketing approval.

Conclusion

• At the end of this project, the Quality Subject Matter Expert with executive experience delivered a comprehensive readiness check for the facility.
  • All the regulatory requirements
  • Inspection readiness recommendations
  • Process and production line validations
  • SOP documentation and training qualifications
• The client was approved by both global regulatory bodies to successfully begin development of their new packaging facility. 

 

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