Forapplication products (i.e., NDAs, ANDAs) this guidance also explains howapplicants should submit NSD controls in original submissions and reportchanges in microbiological specifications and testing programs to the FDA, inaccordance with current Agency guidances regarding changes to an approvedapplicatio...
FDA warns of contaminated ultrasound gelContemporary OB/GYN Staff
Toillustrate the importance of a microbiological risk assessment and controlstrategy, this guidance discusses incidents ofBurkholderia cepaciacomplex (BCC) and other microorganismcontamination in non-sterile dosage forms that resulted in ...
1SeeFDA’sguidances,“MarketingClearanceofDiagnosticUltrasoundSystemsandTransducers,”“Submissionof PremarketNotificationsforMagneticResonanceDiagnosticDevices,”andIEC60601-2-33Edition4.0.Medical electricalequipment-Part2-33:Particularrequirementsforthebasicsafetyandessentialperformanceofmagnetic resonanceequipmentformedical...
NSD产品的微生物污染示例;对产品质量和生产工艺的影响 MicrobiologicalQualityConsiderationsinNon-sterileDrugManufacturingGuidanceforIndustry 行业指南:非无菌药品生产中的微生物质量考量 ⅠINTRODUCTION前言Thisguidance is intended to assist manufacturers in assuring the control ofmicrobiological2 qualityof their non-sterile...
NSD产品的微生物污染示例;对产品质量和生产工艺的影响 MicrobiologicalQualityConsiderationsinNon-sterileDrugManufacturingGuidanceforIndustry 行业指南:非无菌药品生产中的微生物质量考量 ⅠINTRODUCTION前言Thisguidance is intended to assist manufacturers in assuring the control ofmicrobiological2 qualityof their non-sterile...