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A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).

Kelly Waldron1, Amanda McFarland2, Hal Baseman2

  • 1BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA mwjornitz@hotmail.com.

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This article presents a framework for evaluating pre-use/post-sterilization integrity testing (PUPSIT) risks and benefits. It helps assess alternatives to EU Annex 1 requirements using risk management principles for informed decisions.

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Area of Science:

  • Pharmaceutical Science
  • Regulatory Science
  • Risk Management

Background:

  • ICHQ9 guidance was updated in January 2023, enhancing risk-based decision-making for strategic and science-driven choices.
  • Quality risk management supports decision-making but does not negate regulatory compliance obligations.
  • The EU Annex 1 mandates pre-use/post-sterilization integrity testing (PUPSIT), but acknowledges feasibility constraints for small-volume solutions.

Purpose of the Study:

  • To introduce a framework for evaluating the risks and benefits associated with PUPSIT.
  • To provide a structured approach for assessing alternative methods to the EU Annex 1 PUPSIT requirement.
  • To ensure decisions regarding PUPSIT are science- and risk-based, balancing patient safety, process integrity, and regulatory compliance.

Main Methods:

  • Application of risk management principles to evaluate PUPSIT.
  • Development of a framework considering patient safety, process integrity, and regulatory compliance.
  • Assessment of alternative approaches to PUPSIT when direct testing is not feasible, as permitted by EU Annex 1.

Main Results:

  • The framework offers a structured method to assess the acceptability of alternatives to PUPSIT.
  • It guides organizations in conducting comprehensive risk assessments for non-integral filtration systems.
  • It facilitates the implementation of effective controls to mitigate risks associated with filtration.

Conclusions:

  • A science- and risk-based approach enables effective navigation of PUPSIT requirements.
  • Organizations can ensure compliance while addressing operational limitations with the proposed framework.
  • The framework supports informed decision-making for pharmaceutical manufacturing processes involving filtration.