[资源] FDA Current Good Manufacturing Practice (cGMP)

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• 附件 1 : Allowable_Excess_Volume_and_Labeled_Vial_Fill_Size_in_Injectable_Drug_and_Biological_Products.pdf
2016-11-20 22:28:37, 69.85 K
• 附件 2 : Analytical_Proceduresand_Methods_Validationfor_Drugs_and_Biologic.pdf
2016-11-20 22:28:38, 126.69 K
• 附件 3 : CGMP_for_Phase_1_Investigational_Drugs.pdf
2016-11-20 22:28:40, 89.68 K
• 附件 4 : Changes_to_an_Approved_Application_for_Specified_Biotechnology_and_Specified_Synthetic_Biological_Products.pdf
2016-11-20 22:28:40, 30.74 K
• 附件 5 : Charter_of_the_Council_on_Pharmaceutical_Quality.pdf
2016-11-20 22:28:41, 36.57 K
• 附件 6 : Clinical_Development_Programs_for_Drugs,_Devices,_and_Biological_Products.pdf
2016-11-20 22:28:42, 38.61 K
• 附件 7 : Comparability_Protocols_for_Human_Drugs_and_Biologics.pdf
2016-11-20 22:28:44, 191.18 K
• 附件 8 : Completeness_Assessments_for_Type_II_API_DMFs_Under_GDUFA.pdf
2016-11-20 22:28:48, 388.75 K
• 附件 9 : Container_Closure_Systems_for__Packaging_Human_Drugs__and_Biologics.pdf
2016-11-20 22:28:50, 29.43 K
• 附件 10 : Container_Closure_Systems_for_Packaging.pdf
2016-11-20 22:28:53, 157.09 K
• 附件 11 : Cooperative_Manufacturing_Arrangements_for_Licensed_Biologics.pdf
2016-11-20 22:28:54, 103.9 K
• 附件 12 : Current_Good_Manufacturing_Practice_—_Interim_Guidance_for_Human_Drug_Compounding_Outsourcing_Facili.pdf
2016-11-20 22:28:57, 209.46 K
• 附件 13 : Current_Good_Manufacturing_Practice_for_Medical_Gases.pdf
2016-11-20 22:29:00, 320.05 K
• 附件 14 : Current_Good_Manufacturing_Practice_Requirements_for_Combination_Products.pdf
2016-11-20 22:29:03, 289.51 K
• 附件 15 : Data_Integrity_and_Compliance_With_CGMP.pdf
2016-11-20 22:29:05, 112.82 K
• 附件 16 : Drug_Interaction_Studies.pdf
2016-11-20 22:29:12, 849.88 K
• 附件 17 : Early_Clinical_Trials_with_Live_Biotherapeutic_Products.pdf
2016-11-20 22:29:15, 171.43 K
• 附件 18 : Environmental_Assessment_of_Human_Drug_and_Biologics_Applications.pdf
2016-11-20 22:29:17, 182.71 K
• 附件 19 : Established_Conditions-Reportable_CMC_Changes_for_Approved_Drug_and_Biologic_Products.pdf
2016-11-20 22:29:19, 151.54 K
• 附件 20 : for_the_Submission_Documentation_for_Sterilization_Process_Validation.pdf
2016-11-20 22:29:21, 53.24 K
• 附件 21 : FOR_THE_SUBMISSION_OF_CHEMISTRY,_MANUFACTURING,_AND_CONTROLS_INFORMATION.pdf
2016-11-20 22:29:23, 175.9 K
• 附件 22 : Formal_Dispute_Resolution.pdf
2016-11-20 22:29:24, 54.51 K
• 附件 23 : Formal_Dispute_Resolution-Scientific_and_Technical_Issues_Related_to_Pharmaceutical_CGMP.pdf
2016-11-20 22:29:25, 54.5 K
• 附件 24 : IND_Meetings_for_Human_Drugs_and_Biologics.pdf
2016-11-20 22:29:25, 27.84 K
• 附件 25 : Investigating_Out-of-Specification_(OOS)_Test_Results_for_Pharmaceutical_Production.pdf
2016-11-20 22:29:27, 82.96 K
• 附件 26 : Manufacturing_Biological_Intermediates_and_Biological_Drug_Substances_Using_Spore-Forming_Microorgan.pdf
2016-11-20 22:29:29, 120.52 K
• 附件 27 : Manufacturing_Biological_Intermediates_and_Biological_Drug_Substances_Using_Spore-Forming_Microorganisms.pdf
2016-11-20 22:29:31, 120.52 K
• 附件 28 : Monoclonal_Antibodies_Used_as_Reagents_in_Drug_Manufacturing.pdf
2016-11-20 22:29:32, 27.59 K
• 附件 29 : Nonclinical_Studies_for_the_Safety_Evaluation_of_Pharmaceutical_Excipients.pdf
2016-11-20 22:29:34, 213.22 K
• 附件 30 : Part_11,_Electronic_Records;_Electronic_Signatures.pdf
2016-11-20 22:29:35, 39.49 K
• 附件 31 : PAT_—_A_Framework_for_Innovative_Pharmaceutical_Development,_Manufacturing,_and_Quality_Assurance.pdf
2016-11-20 22:29:38, 207.86 K
• 附件 32 : PET_Drugs_—_Current_Good_Manufacturing_Practice_(CGMP).pdf
2016-11-20 22:29:40, 166.12 K
• 附件 33 : Pharmaceutical_cGMPS_for_the_21st_Century.pdf
2016-11-20 22:29:43, 204.36 K
• 附件 34 : PRE-APPROVAL_INSPECTIONS.pdf
2016-11-20 22:29:47, 401.61 K
• 附件 35 : Prioritizing_CGMP_Inspections_ofPharmaceutical_Manufacturing_Sites.pdf
2016-11-20 22:29:49, 130.96 K
• 附件 36 : Process_Validation.pdf
2016-11-20 22:29:52, 328.27 K
• 附件 37 : Q7_Good_ManufacturingPractice_Guidance_for_ActivePharmaceutical_Ingredients.pdf
2016-11-20 22:29:55, 232.78 K
• 附件 38 : QUALITY_METRICS_TECHNICAL_CONFORMANCE_GUIDE.pdf
2016-11-20 22:29:56, 106.96 K
• 附件 39 : Quality_Systems_Approach_to_Pharmaceutical_CGMP_Regulations.pdf
2016-11-20 22:30:00, 357.83 K
• 附件 40 : Quality_Systems_Approach_to_Pharmaceutical_Current_Good_Manufacturing_Practice_Regulations.pdf
2016-11-20 22:30:03, 357.88 K
• 附件 41 : Request_for_Quality_Metrics.pdf
2016-11-20 22:30:06, 233.43 K
• 附件 42 : Sterile_Drug_Products_Produced_by_Aseptic_Processing_—_Current_Good_Manufacturing_Practice.pdf
2016-11-20 22:30:11, 527.39 K
• 附件 43 : Sterile_Drug_Products.pdf
2016-11-20 22:30:16, 527.4 K
• 附件 44 : Submission_of_Documentation_in_Applications_for_Parametric_Release_of_Human.pdf
2016-11-20 22:30:17, 54.98 K
• 附件 45 : The_Use_of_Mechanical_Calibration_of_Dissolution_Apparatus_1_and_2_–_Current_Good_Manufacturing_Prac.pdf
2016-11-20 22:30:19, 97.16 K
• 附件 46 : UCM070315.pdf
2016-11-20 22:30:26, 794.01 K

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