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05.31.24 -- FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies

05.31.24 -- FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
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05.21.24 -- Addressing Challenges In Serialization For Complex Therapeutics

05/21/24 Pharmaceutical Online Newsletter ....

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05.16.24 -- New Initiative Seeks To Back Up ICH's Harmonization Mission

05.16.24 -- New Initiative Seeks To Back Up ICH's Harmonization Mission
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Ensuring environmental monitoring solutions meet GMP requirements

This article explores environmental monitoring solutions when it comes to GMP applications. ....

Aimee Molineux , Mark Hallworth , European Union Volume , European Commission , International Standards Organization , Sponsored Content , Particle Measuring Systemsdec , Image Credit , Particle Measuring , Light Scattering Aerosol Particle Counter , Clean Areas , Contamination Control Strategy , Facility Monitoring System , Environment Monitoring , Environmental Monitoring Risk Assessment , Industrial Automation , Supervisory Control , Data Acquisition , Standard Operating Procedures , User Requirement Specification , Monitoring Systems , Rules Governing Medicinal Products , Good Manufacturing Practice , Medicinal Products , Veterinary Use , Sterile Medicinal Products ,

Annex 1 revision now effective

Annex 1 revision now effective
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European Commission , Novo Nordisk , Technical University Of Denmark , Revised Annex , Sterile Medicinal Products , Contamination Control Strategy , Pharmaceutical Quality System , Quality Risk Management , Environmental Monitoring In Depth Focus , Isabella Jul J , Technical University ,