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Articles by Magnus Stering
Análisis de los efectos en modo de falla para el estudio de integridad del filtro
Alcance del FMEA para el FIT El propósito del FMEA para el FIT es establecer evidencia documentada para asegurar que el proceso de manufactura es capaz de producir las especificaciones de calidad pre-determinadas cuando se usa un probador más específico para el análisis de integridad de filtros, garantizando mientras tanto la seguridad del operador.
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
By Magnus Stering is senior product manager, Integrity Testing Solutions, Sartorius Quality risk management (QRM) is a systematic process for assessment, control, communication, and review of risks to the quality of a pharmaceutical product across its lifecycle.
05.27.21 -- Small Molecule Drug Substance Outsourcing
By ISR Reports In Q4 2020, ISR asked 123 outsourcers of small molecule API about the proportion of manufacturing allocated across three different approaches to outsourcing: tactical outsourcing, preferred providers, and strategic partnerships. The data show that the largest proportion of work is allocated tactically (38%), but that is expected to shift to preferred providers (41%) over the next three years as more outsourcing companies establish preferred relationships. By S. D.
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
By Magnus Stering is senior product manager, Integrity Testing Solutions, Sartorius Quality risk management (QRM) is a systematic process for assessment, control, communication, and review of risks to the quality of a pharmaceutical product across its lifecycle.
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
By Magnus Stering is senior product manager, Integrity Testing Solutions, Sartorius Quality risk management (QRM) is a systematic process for assessment, control, communication, and review of risks to the quality of a pharmaceutical product across its lifecycle.
Sartocheck 5 Plus Filter Integrity Tester Addresses Regulatory Requirements - BioProcess International
Sartocheck 5 Plus filter integrity tester Filter integrity is a fundamental element of sterility assurance during production of biopharmaceutical and vaccine products. Integrity test results are a key foundation for drug lot release, so any external element that could affect their reliability must be viewed as a critical issue. But when should a filter integrity test be performed? This article highlights the Sartocheck 5 Plus filter integrity tester as a means to address regulatory requirements.
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