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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 compliance.

Keywords:
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Area of Science:

  • Pharmaceutical Quality Risk Management
  • Sterile Product Manufacturing
  • Regulatory Compliance

Background:

  • The International Council for Harmonisation (ICH) Q9 guideline was updated in January 2023, enhancing guidance on risk-based decision-making for science-driven strategies.
  • Regulatory requirements must still be met, even when utilizing quality risk management (QRM) for decision support.
  • European Union (EU) Annex 1 mandates pre-use/post-sterilization integrity testing (PUPSIT), but acknowledges feasibility constraints for certain processes, like small-volume filtration.

Purpose of the Study:

  • To introduce a structured framework for evaluating the risks and benefits associated with PUPSIT.
  • To provide a science- and risk-based approach for assessing the acceptability of alternative methods to the EU Annex 1 PUPSIT requirement.
  • To ensure decisions regarding PUPSIT alternatives are well-informed, balanced, and compliant with regulatory expectations.

Main Methods:

  • Development of a risk management framework specifically tailored for PUPSIT evaluation.
  • Consideration of three critical domains: patient safety, process integrity, and regulatory compliance.
  • Application of risk assessment principles to determine the suitability of alternative controls when PUPSIT is not feasible.

Main Results:

  • The proposed framework enables a systematic evaluation of risks and benefits associated with PUPSIT.
  • It facilitates the assessment of alternative strategies to meet EU Annex 1 requirements when PUPSIT presents challenges.
  • The framework supports informed decision-making by balancing operational realities with patient safety and regulatory adherence.

Conclusions:

  • Organizations can effectively navigate PUPSIT requirements using a science- and risk-based approach.
  • The framework allows for compliance with regulatory expectations while addressing practical limitations in sterile filtration processes.
  • Implementing this approach ensures robust risk mitigation for non-integral filtration systems.