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Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy FacilitiesManufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
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Quality Quartets in Risk-Based Qualification: ICH Q9(R1) ConsiderationsQuality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
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Remote Inspections - Lessons LearnedThis article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
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Ensuring Container Closure Integrity (CCI) for Products requiring Deep Cold Storage by correlating Seal Quality to CCIAs described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI. This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage
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Pharmacovigilance AutomationOrganizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.
