D2S18-Aldridge-v1.2-FINAL.pdf

1、Top Ten Deficiencies for Liquid Drug ProductsAllison A.Aldridge,Ph.D.*Perpetue Bataille Backer,Ph.D.,Christopher Mayer-Bacon,Ph.D.,Sateesh Sathigari,Ph.D.Consumer Safety OfficerOPMA/OPQCDER|US FDAGeneric Drugs Forum (GDF)April 22-23January 16,2020www.fda.govwww.fda.gov2This presentation reflects the

2、 views of the speaker and should not be construed to represent FDAs views or policiesDisclaimer3Pharmaceutical quality assures the availability,safety,and efficacy of every dose.Everyone deserves confidence in their next dose of medicine.www.fda.govwww.fda.gov4 Mission:Quality pharmaceuticals are co

3、nsistently manufactured over product lifecycle Vision:To be the premier global regulatory organization for holistic assessmentOffice of Pharmaceutical Manufacturing Assessmentwww.fda.govwww.fda.gov5Office of Pharmaceutical Manufacturing Assessment,contdDivisions I VI 3 Units eachProcess,Facility and

4、 Microbiology assessorsANDA,NDA,BLA*Spans Therapeutic Areas&ProductsAcross Product Lifecycle One Quality Voice through Integrated Quality Assessment teamswww.fda.govwww.fda.gov6FDA efforts to expedite drug approvalsAnalyze common manufacturing deficiency trendsReview top ten deficienciesIdentify doc

5、uments to help applicants with submissionsLearning Objectiveswww.fda.govwww.fda.gov7 Sending information requests(IRs)and discipline letters(DRLs)late in the assessment cycle(GDUFA III)Four Part Harmony(PDUFA VII)for IRsFDA Enhancementswww.fda.govwww.fda.gov8 Acknowledge information provided Identif

6、y the issue Identify information required to make a regulatory decision Provide specific reference or information to support requestFour Part Harmonywww.fda.govwww.fda.gov Injectables Oral dosage forms Topicals InsufflatesLiquid Drug Productswww.fda.govwww.fda.gov10Poll QuestionWhich unit operation