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Primary Packaging Line Cleaning Validation

Project: Cleaning Validation Program Development Primary Packaging

  

 

Duration- 4 months

Overview:

Developed the cleaning validation program and performed cleaning validation at a multi-product drug product repacker with over 90 different active ingredients.  A full revamp of their cleaning validation program was required including the development of a product cleaning risk matrix that evaluated each product on toxicity, solubility, and cleanliness.  From this matrix, representative compounds were selected as the most challenging products to clean and used to demonstrate the equipment cleaning process was both effective and reproducible. 

In addition, the product contact equipment was assessed for the worst case locations from a cleaning perspective and sample site diagrams were created to ensure a consistent approach to cleaning validation/verification sampling would be applied for future activities.  

 Scope of Work:

The cleaning validation scope included: 

  • Identification of the worst case product from a cleaning and risk standpoint
  • Development of a Cleaning Validation Master Plan
  • Development of a product cleaning risk matrix
  • Evaluation of the worst case locations for swabbing
  • Development of Swab Sampling diagrams
  • Cleaning Validation protocol development, execution, and summation 

 

 

TrackWise Modifications for Change Management

TrackWise Change Management Workflow Qualification

Duration- 4 months

Overview:

Commission and Qualify the new Change Management group of workflows in TrackWise. The new Change Management project included 5 workflows (3 new and 2 modifications of existing workflows). The Change Management workflows will be utilized at the three sites and qualified for use at each division and additionally as a global division for managing changes shared across sites.

 Scope of Work:

The project scope included:

  • Risk Assessment Development and Approval
  • Functional Testing (Development and Quality Systems)
  • Protocol Development and Execution
  • Training Development
  • SOP Review and Support

The Mangan team collaborated with the IT and Quality department to qualify the Change Management workflows within TrackWise, in addition, helped support use of the system through Training development and SOP reviews.

Outcome:

The Change Management workflows were qualified for GMP use and implemented successfully globally.