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- 附件 1 : Annex_1Manufacture_of_Sterile_Medicinal_Products.pdf
2016-11-20 21:32:13, 121.63 K
- 附件 2 : Annex_2Manufacture_of_Biological_active_substances_and_Medicinal_Products_for_Human_Use.pdf
2016-11-20 21:32:17, 170.73 K
- 附件 3 : Annex_3Manufacture_of_Radiopharmaceuticals.pdf
2016-11-20 21:32:19, 67.3 K
- 附件 4 : Annex_4Manufacture_of_Veterinary_Medicinal_Products_other_than_Immunological_Veterinary_Medicinal_Products.pdf
2016-11-20 21:32:21, 13.85 K
- 附件 5 : Annex_5Manufacture_of_Immunological_Veterinary_Medicinal_Products.pdf
2016-11-20 21:32:24, 42.2 K
- 附件 6 : Annex_6Manufacture_of_Medicinal_Gases.pdf
2016-11-20 21:32:26, 47.44 K
- 附件 7 : Annex_7Manufacture_of_Herbal_Medicinal_Products.pdf
2016-11-20 21:32:28, 22.03 K
- 附件 8 : Annex_8SAMPLING_OF_STARTING_AND_PACKAGING_MATERIALS.pdf
2016-11-20 21:32:30, 19.35 K
- 附件 9 : Annex_9MANUFACTURE_OF_LIQUIDS,_CREAMS_AND_OINTMENTS.pdf
2016-11-20 21:32:32, 12.54 K
- 附件 10 : Annex_10Manufacture_of_Pressurised_Metered_Dose_Aerosol_Preparations_for_Inhalation.pdf
2016-11-20 21:32:34, 16.83 K
- 附件 11 : Annex_11Computerised_Systems.pdf
2016-11-20 21:32:36, 21.94 K
- 附件 12 : Annex_12Use_of_Ionising_Radiation_in_the_Manufacture_of_Medicinal_Products.pdf
2016-11-20 21:32:39, 49.24 K
- 附件 13 : Annex_13Investigational_Medicinal_Products.pdf
2016-11-20 21:32:41, 66.29 K
- 附件 14 : Annex_14Manufacture_of_Medicinal_Products_Derived_from_Human_Blood_or_Plasma.pdf
2016-11-20 21:32:43, 49.69 K
- 附件 15 : Annex_15Qualification_and_Validation.pdf
2016-11-20 21:32:46, 94.17 K
- 附件 16 : Annex_16Certification_by_a_Qualified_Person_and_Batch_Release.pdf
2016-11-20 21:32:49, 242.13 K
- 附件 17 : Annex_17Parametric_Release.pdf
2016-11-20 21:32:51, 123.03 K
- 附件 18 : Annex_17Real_Time_Release_Testing(UPDATE).pdf
2016-11-20 21:32:53, 240.44 K
- 附件 19 : Annex_19Reference_and_Retention_Samples.pdf
2016-11-20 21:32:54, 23.09 K
- 附件 20 : Chapter_1-Pharmaceutical_Quality_System.pdf
2016-11-20 21:32:55, 64.3 K
- 附件 21 : Chapter_2_-_Personnel.pdf
2016-11-20 21:32:56, 57.46 K
- 附件 22 : Chapter_3_-_Premise_and_Equipment.pdf
2016-11-20 21:32:58, 170.57 K
- 附件 23 : CHAPTER_3_PREMISES_AND_EQUIPMENT（update）.pdf
2016-11-20 21:32:59, 33.4 K
- 附件 24 : Chapter_4_-_Documentation.pdf
2016-11-20 21:33:00, 32.53 K
- 附件 25 : Chapter_5_-_Production.pdf
2016-11-20 21:33:03, 285.28 K
- 附件 26 : CHAPTER_5_PRODUCTION(UPDATE).pdf
2016-11-20 21:33:04, 49.14 K
- 附件 27 : Chapter_6_-_Quality_Control.pdf
2016-11-20 21:33:05, 44.03 K
- 附件 28 : Chapter_7_-_Outsourced_activities.pdf
2016-11-20 21:33:05, 20.62 K
- 附件 29 : Chapter_8_-_Complaints_and_Product_Recall.pdf
2016-11-20 21:33:08, 265.74 K
- 附件 30 : Chapter_9_-_Self_Inspection.pdf
2016-11-20 21:33:09, 10.07 K
- 附件 31 : Compilation_of_Community_Procedures_on_Inspections_and_Exchange_of_Information_updated_to_include_new_EU_formats_and_procedures.pdf
2016-11-20 21:33:22, 1.49 M
- 附件 32 : Glossary.pdf
2016-11-20 21:33:24, 26.97 K
- 附件 33 : Guidelines_of_19_March_2015_on_principles_of_Good_Distribution_Practice_of_active_substances_for_medicinal_products_for_human_use.pdf
2016-11-20 21:33:30, 501.65 K
- 附件 34 : Introduction.pdf
2016-11-20 21:33:33, 32.08 K
- 附件 35 : Part_II__Basic_Requirements_for_Active_Substances_used_as_Starting_Materials.pdf
2016-11-20 21:33:41, 613.94 K
- 附件 36 : Part_III_7_Guidelines_of_19_March_2015_on_the_formalised_risk_assessment_for_ascertaining_the_appropriate_good_manufacturing_practice_for_excipients_of_medicinal_products_for_human_use.pdf
2016-11-20 21:33:46, 307.19 K
- 附件 37 : Part_III_A_risk_assessment_as_set_out_in_these_guidelines_should_be_carried_out_for_excipients_for_authorised_medicinal_products_for_human_use_by_21_March_2016..pdf
2016-11-20 21:33:51, 307.19 K
- 附件 38 : Part_III_Guideline_on_setting_health_based_exposure_limits_for_use_in_risk_identification_in_the_manufacture_of_different_medicinal_products_in_shared_facilities.pdf
2016-11-20 21:33:55, 169.13 K
- 附件 39 : Part_III_MRA_Batch_Certificate.pdf
2016-11-20 21:33:58, 100.31 K
- 附件 40 : Part_III_Q9_Quality_Risk_Management.pdf
2016-11-20 21:34:01, 330.64 K
- 附件 41 : Part_III_Q10_Note_for_Guidance_on_Pharmaceutical_Quality_System.pdf
2016-11-20 21:34:07, 361.39 K
- 附件 42 : Part_III_-Site_Master_File.pdf
2016-11-20 21:34:08, 32.22 K
- 附件 43 : Part_III_Template_for_the_written_confirmation_for_active_substances_exported_to_the_European_Union_for_medicinal_products_for_human_use.pdf
2016-11-20 21:34:12, 486.8 K
- 附件 44 : Volume_4_-_Good_Manufacturing_Practice_(GMP)_guidelines.pdf
2016-11-20 21:34:16, 365.83 K
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