SFQRM: Strategy roadmap for the implementation of a risk-based approach to pre-use post-sterilization integrity testing (Pupsit)

How do companies use scientific data and risk-based approaches to make and defend decisions related to Pre-Use Post Sterilization Integrity Testing (PUPSIT)?

To support informed decision-making, the PDA and BioPhorum Sterile Filtration Quality Risk Management (SFQRM) Consortium have published data and methodology relating to the implementation of a risk-based approach to PUPSIT.

In addition, subject matter experts from the SFQRM Consortium has prepared this strategy roadmap with suggested actions and considerations to support the implementation of an effective risk-based approach:

  • Risk assessment (RA) and risk mitigation
  • Evaluate potential fouling behavior
  • Revise internal standards
  • Communicate and educate
  •  Build awareness of internal stakeholders
  • Work with contract manufacturing organizations (CMOs).

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Strategy roadmap for the implementation of a risk-based approach to pre-use post-sterilization integrity testing (Pupsit).pdf
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  • Create Date 27th November 2020
  • DOI https://doi.org/10.46220/2020FF003
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Technology Strategy
Buffer stock blending system
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Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
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Digital plant maturity model
IT for cell and gene therapies
Lab of the future
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