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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.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Using Industry 4.0 to Optimize Oral Solid Dosage Form ManufacturingReal-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
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Qualification of a Swab Sampling Procedure for Cleaning ValidationThe authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
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Qualification of a Swab Sampling Procedure for Cleaning ValidationThe authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
