1、MediPearl GMP Documents Index (3) EquipmentPage 1 of 12(3) Equipment Management DocumentsClassifications Code Documents Name RemarksE/DF/00100 Production Main Equipment Layout ViewE/DF/00200 Production Main Equipment OverviewDrawingsE/DF/00300 Calibration Instruments Equipment OverviewE/SMP/00100 Eq
2、uipment Select and Supplier Audit Management Procedures E/SMP/00200 Equipment Used and Maintenance Management Procedures E/SMP/00300 Equipment installation and debugging Management Procedures E/SMP/00400 Equipment Spare Parts Management ProceduresE/SMP/00500 Equipment Archive Management ProceduresE/
3、SMP/00600 Package Opening and Acceptance Management Procedures E/SMP/00700 Filters Equipment Management ProceduresE/SMP/00800 Equipment Incidents Management ProceduresE/SMP/00900 Equipment Routine Inspection Management ProceduresE/SMP/01000 Equipment Status Labels Management Procedures Management St
4、andardE/SMP/01100 Equipment Lubricating Management proceduresMediPearl GMP Documents Index (3) EquipmentPage 2 of 12E/SMP/01200 Equipment Related Lubricants and Coolants Usage Management Procedures E/SMP/01300 Metrological Instrument Management Procedures.E/SMP/01400 Pressure Vessels Management Proc
5、edures E/SMP/01500 Production and Inspection Used Instruments, Gauges, Measuring Tools and Weighing Scales of Calibration Management Procedures E/SMP/01600 Test Instrument and Equipment Usage Management Procedures E/SMP/01700 Container Usage Management ProceduresE/SMP/01800 Equipment and Pipelines C
6、olour Code Management Procedures. E/SMP/01900 Equipment Piping Rotten Prevention and Insulation Management ProceduresE/SMP/02000 Sealed Management ProceduresE/SMP/02100 Safety Inspection and Repaired Management ProceduresE/SMP/02200 Equipment Inspection and Repairing in Power Cut-off Management Proc
7、edures E/SMP/02300 Purified Water Manufacture, Storage and Distribution Usage Management ProceduresE/SMP/02400 Purified Water System Maintenance Management Procedures.MediPearl GMP Documents Index (3) EquipmentPage 3 of 12E/SMP/02500 Equipment Classification code StandardProduction Main Equipment SO
8、PE/SOP/O/00100 Nauta Vacuum Dryer SOPE/SOP/O/00200 Dry Granulation Unit SOPE/SOP/O/00300 ACB Conical Blender SOP E/SOP/O/00400 ACF-20 Automatic Capsule Filling Machine SOPE/SOP/O/00500 CY 102 Polishing Machine SOPE/SOP/O/00600 XL 100 Tableting Machine SOPE/SOP/O/00700 Labcoat IIX Tablet Coating Syst
9、em SOPE/SOP/O/00800 DK-PS 3000A Blister Packing Machine SOPE/SOP/O/00900 Chilling Machine SOPE/SOP/O/01000 YC-WH-300 YenChen Washing Machine SOPE/SOP/O/01100 YC-TC-500 YenChen Cutting Machine SOPE/SOP/O/01200 YC-DO-1C YenChen Drying Oven SOPE/SOP/O/01300 Extraction Equipment SOPE/SOP/O/01400 Evapora
10、tion Equipment SOPE/SOP/O/01500 Ethanol Rectification Equipment SOPStandard Operating ProceduresE/SOP/O/01600 Vacuum Dryer (E&E) SOPMediPearl GMP Documents Index (3) EquipmentPage 4 of 12E/SOP/O/01700 Cooling Water System SOPE/SOP/O/01800 Cold Room System SOPE/SOP/O/01900 Transfer and Storage of Pur
11、ified Water SOP E/SOP/O/02000 Purified Water System SOPE/SOP/O/02100 Boiler Operating System SOPE/SOP/O/02200 Oil-Free System Air Compressor SOPE/SOP/O/02300 Automatic Hands Dryer SOPE/SOP/O/02400 Electronic Clock with Thermometer and Hygrometer SOPE/SOP/O/02500 Spray Code Machine SOPE/SOP/O/02600 W
12、ashing Machine SOP for Company UniformsE/SOP/O/02700 Air Flow Meter SOPE/SOP/O/02800 Clean Sampling Trolley SOPE/SOP/O/02900 Sterilization Oven SOPMain Production Equipment Maintenance SOPE/SOP/M/00100 Nauta Vacuum Dryer Maintenance SOPE/SOP/M/00200 Dry Granulation Unit Maintenance SOPE/SOP/M/00300
13、ACB 100 Conical Blender Maintenance SOPE/SOP/M/00400 ACF-20 Automatic Capsule Filling Machine Maintenance SOPMediPearl GMP Documents Index (3) EquipmentPage 5 of 12E/SOP/M/00500 CY 102 Capsule Polishing Machine Maintenance SOPE/SOP/M/00600 XL 100 Tableting Machine Maintenance SOPE/SOP/M/00700 Labcoa
14、t IIX Tablet Coating System Maintenance SOPE/SOP/M/00800 DK-PS 3000A Blister Packing Machine Maintenance SOPE/SOP/M/00900 Chilling Machine Maintenance SOPE/SOP/M/01000 YC-WH-300 YenChen Washing Machine Maintenance SOPE/SOP/M/01100 YC-TC-500 YenChen Cutting Machine Maintenance SOPE/SOP/M/01200 YC-DO-
15、1C YenChen Drying Oven Maintenance SOPE/SOP/M/01300 Extraction Equipment Maintenance SOPE/SOP/M/01400 Evaporation Equipment Maintenance SOPE/SOP/M/01500 Ethanol Rectification Equipment Maintenance SOPE/SOP/M/01600 Vacuum Dryer (E&E) Maintenance SOPE/SOP/M/01700 Cooling Water System Maintenance SOPE/
16、SOP/M/01800 Cold Room System SOPE/SOP/M/01900 Transfer and Storage of Purified Water Maintenance SOPE/SOP/M/02000 Purified Water System Maintenance SOP E/SOP/M/02100 Boiler Operating System Maintenance SOPE/SOP/M/02200 Oil-Free System Air Compressor Maintenance SOPMediPearl GMP Documents Index (3) E
17、quipmentPage 6 of 12E/SOP/M/02300 Automatic Hands Dryer Maintenance SOPE/SOP/M/02400 Electronic Clock with Thermometer and Hygrometer Maintenance SOPE/SOP/M/02500 Spray Code Machine Maintenance SOPE/SOP/M/02600 Washing Machine Maintenance SOP for Company UniformsE/SOP/M/02700 Air Flow Meter Maintena
18、nce SOPE/SOP/M/02800 Clean Sampling Trolley Maintenance SOPE/SOP/M/02900 Sterilization Oven Maintenance SOPChecking Instruments SOPE/SOP/I/00100 Biological Microscope SOPE/SOP/I/00200 Microbial Cultivating Compartment SOPE/SOP/I/00300 Electronic Balance SOPE/SOP/I/00400 pH Meter SOPE/SOP/I/00500 Ele
19、ctrical Oven SOPE/SOP/I/00600 Electrical Distillation SOPE/SOP/I/00700 Moisture Content Checking SOPE/SOP/I/00800 Electrical Water Bath SOPE/SOP/I/00900 Ultrasonic Cleaner SOPMediPearl GMP Documents Index (3) EquipmentPage 7 of 12E/SOP/I/01000 Electromantle SOPE/SOP/I/01100 Electrical Temperature Co
20、ntrol SOPE/SOP/I/01200 High Performance Liquid Chromatography Instrument SOP E/SOP/I/01300 Ultra-violet Analysis Instrument SOPE/SOP/I/01400 Vibrator SOPE/SOP/I/01500 Refrigerator SOPE/SOP/I/01600 Dust Particles Count Instrument SOP E/SOP/I/01700 Drying Oven SOP E/SOP/I/01800 UV Spectrophotometer In
21、strument SOPE/SOP/I/01900 Bacteria Cultivation Compartment SOPE/SOP/I/02000 High Temperature Oven SOPE/SOP/I/02100 Electronic Pipettor SOPE/SOP/I/02200 High Pressurize Bacteria Eradicator SOPE/SOP/I/02300 Microbial Detector SOPE/SOP/I/02400 Intelligence Crushing Instrument SOPE/SOP/I/02500 Atom Abso
22、rption Spectrophotometer SOPE/SOP/I/02600 Alcohol meter SOPMediPearl GMP Documents Index (3) EquipmentPage 8 of 12E/SOP/I/02700 BECKMAN COULTER Avanti J-E Centrifuge Configuration SOPE/SOP/I/02800 BECKMAN COULTER Avanti J-E Centrifuge SOPE/SOP/I/02900 Buchi Rotavapor R-124 and Buchi Oil bath B-485 S
23、OPE/SOP/I/03000 Chinese Medicinal Herb Slicer Clean up SOPE/SOP/I/03100 Chinese Medicinal Herb Slicer SOPE/SOP/I/03200 Conterm Series Five Oven SOPE/SOP/I/03300 ELMA TRANSSONIC Cleaning Bath Clean up SOPE/SOP/I/03400 ELMA TRANSSONIC Cleaning Bath SOPE/SOP/I/03500 EYELA Aspirator SOPE/SOP/I/03600 EYE
24、LA Circulation Cooling Aspirator SOPE/SOP/I/03700 Gelman Biological Safety Cabinet SOPE/SOP/I/03800 Sanyo Harrier Centrifuge SOPE/SOP/I/03900 Sanyo MCO-17AIC CO2 Incubator SOPE/SOP/I/04000 Satorius MA45 Moisture Analyzer Configuration SOPE/SOP/I/04100 Satorius MA45 Moisture Analyzer SOPE/SOP/I/04200
25、 SCHOTT CG842 pH Meter Calibration SOPE/SOP/I/04300 SCHOTT CG842 pH Meter SOPMediPearl GMP Documents Index (3) EquipmentPage 9 of 12E/SOP/I/04400SD-1 Multifunctional Experimental Pharmaceutical Machinery SOPE/SOP/I/04500 STERIS Prevacuum Sterilizer SOP E/SOP/I/04600 STERIS Prevacuum Sterilizer SOPE/
26、SOP/I/04700 Vacuum Oven Thermoline L+M TVO-35 SOPE/SOP/I/04800 Yuan Tai Chi Marvelous Grinding Machine SOPChecking Instrument Maintenance ProceduresE/SOP/IM/00100 Biological Microscope Maintenance Procedures E/SOP/IM/00200 Microbial Cultivating Compartment Maintenance ProceduresE/SOP/IM/00300 Electr
27、onic Balance Maintenance Procedures E/SOP/IM/00400 pH Meter Maintenance ProceduresE/SOP/IM/00500 Electrical Oven Maintenance ProceduresE/SOP/IM/00600 Electrical Distillation Maintenance ProceduresE/SOP/IM/00700 Moisture Content Checking Maintenance ProceduresE/SOP/IM/00800 Electrical Water Bath Main
28、tenance ProceduresE/SOP/IM/00900 Ultrasonic Cleaner Maintenance ProceduresE/SOP/IM/01000 Electromantle Maintenance ProceduresE/SOP/IM/01100 Electrical Temperature Control Maintenance ProceduresMediPearl GMP Documents Index (3) EquipmentPage 10 of 12E/SOP/IM/01200 High Performance Liquid Chromatograp
29、hy Instrument Maintenance ProceduresE/SOP/IM/01300 Ultra-violet Analysis Instrument Maintenance ProceduresE/SOP/IM/01400 Vibrator Maintenance ProceduresE/SOP/IM/01500 Refrigerator Maintenance ProceduresE/SOP/IM/01600 Dust Particles Count Instrument Maintenance ProceduresE/SOP/IM/01700 Type Electrica
30、l Drying Oven Maintenance ProceduresE/SOP/IM/01800 UV Spectrophotometer Instrument Maintenance ProceduresE/SOP/IM/01900 Bacteria Cultivation Compartment Maintenance ProceduresE/SOP/IM/02000 High Temperature Oven Maintenance ProceduresE/SOP/IM/02100 Electronic Pipettor Maintenance ProceduresE/SOP/IM/
31、02200 High Pressurize Bacteria Eradicator Maintenance ProceduresE/SOP/IM/02300 Microbial Detector Maintenance ProceduresE/SOP/IM/02400 Intelligence Crushing Instrument Maintenance ProceduresE/SOP/IM/02500 Atom Absorption Spectrophotometer Maintenance ProceduresEquipment, Instruments and Other Record
32、sE/R/00100 Equipment Purchasing Application FormMediPearl GMP Documents Index (3) EquipmentPage 11 of 12E/R/00200 Gauges and Metering Instrument Purchasing RecordsE/R/00300 Equipment Case Opening Inspection RecordsE/R/00400 Equipment Record CardsE/R/00500 Equipment Easy Damage Fittings ListingE/R/00
33、600 Equipment Installation Debug Acceptance ListE/R/00700 Equipment Registration FormE/R/00800 Inspection Instrument (Equipment)Used Records TableE/R/00900 Daily Equipment Maintenance and Lubrication RecordsE/R/01000 Equipment Inspection and Maintenance RecordsE/R/01100 Boiler Operating RecordsE/R/0
34、1200 Purified Water System Maintenance RecordsE/R/01300 Purified Water Preparation, Storage and Distribution RecordsE/R/01400 Purified Water System Inspection RecordsE/R/01500 Piping Chemical Cleaning RecordsE/R/01600 Metering Instruments Calibration Records E/R/01700 Routine Servicing RecordsE/R/01
35、800 Equipment Yearly Inspection ScheduleE/R/01900 Metering Instruments AccountMediPearl GMP Documents Index (3) EquipmentPage 12 of 12E/R/02000 Glass Apparatus Issuing RecordsE/R/02100 Metering Instruments Receiving Records E/R/02200 Metering Instruments Routine Inspection ScheduleE/R/02300 Metering
36、 Instruments Inspection and Scrap RecordsE/R/02400 Production Equipment Used RecordsE/R/02500 Purified Water Piping Disinfection RecordsE/R/02600 Process Water Used Sampling FormsDefinition:-E : EquipmentR : RecordsSOP : Standard Operating ProceduresDF : Drawing and FormM : MaintenanceI : InstrumentIM : Instrument MaintenanceO : Operation
