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Factory Acceptance Testing Site Acceptance Testing Commissioning Activities Oh My!

Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a.

Ciona forsytheAjay pazhayattilPraveen josephCustomer organizationInternational society for pharmaceutical engineeringParenteral drug associationJournal of validation technologyInternational societyPharmaceutical engineeringKey to minimizing downstreamResponsibility matrix for optimalBaseline guidancePractical approachQualificationa symbiotic relationshipProcess validationGeneral principles

The Data Integrity Body of Knowledge Expands with New Pending Guidances

Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained.

United statesUnited kingdomInternational society for pharmaceutical engineeringInspection coExpert committee on specifications for pharmaceutical preparationsEuropean unionWorld health organization guidanceInternational conference on harmonisationDrug administrationWorld health organizationEuropean commissionRegulatory agencyInspection conventionEuropean medicines agencyHealth canadaExpert committee

The Data Integrity Body of Knowledge Expands with New Pending Guidances

Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained.

United statesUnited kingdomInternational society for pharmaceutical engineeringInspection coExpert committee on specifications for pharmaceutical preparationsEuropean unionWorld health organization guidanceInternational conference on harmonisationDrug administrationWorld health organizationEuropean commissionRegulatory agencyInspection conventionEuropean medicines agencyHealth canadaExpert committee

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