Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.
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The revised European Union good manufacturing practice (EU GMP) Annex 1 guidance document (1), which was published on Aug. 25, 2022 and came into effect on Aug. 25, 2023, is a more detailed and comprehensive guideline that aims to enhance process understanding and incorporate new innovative tools. The updated Annex 1 also takes into account changes in regulatory and manufacturing environments. However, it is important to examine how the requirements for liquid sterilizing grade filtration within the revised Annex 1 align with technological advancements and contamination control assurance. This paper aims to review technology advances in filtration and identify areas that require clarification in the Annex 1 guidelines.
Sterilizing-grade filtration is a widely used method for sterilizing biologics, and it has become increasingly prevalent due to improvements in filter and membrane stability, advanced integrity tests, new design and chemistry features, and process validation activities. These advancements have significantly increased the reliability of aseptic processing steps using sterilizing grade filters, necessarily so; as for most biologics, sterile filtration is the only means of sterilization.
Modern sterilizing-grade membrane filters are designed and built to meet the strict requirements of the biopharmaceutical industry and regulatory authorities. These filters have undergone continuous optimization and development, resulting in several important features:
Read this article in Pharmaceutical Technology®/Pharmaceutical Technology Europe® Quality and Regulatory Sourcebook eBook.
Maik Jornitz is principal consultant, BioProcess Resources LLC
Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook 2024
March 2024
Pages: 10–13
When referring to this article, please cite it as Jornitz, M. Filtration Clarification Needs in Annex 1. Pharmaceutical Technology®/Pharmaceutical Technology Europe® Quality and Regulatory Sourcebook eBook (March 2024).
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