KS J 0014-2010 Bioindustry－Preparation of standard operating procedure and its application for bioindustrial process《生物产业 工程的标准作业程序制定及实施》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS J 0014 KS J 0014:2010 2010 12 24 http:/www.kats.go.krKS J 0014:2010 : ( ) ( ) KT&G ( ) : (http:/www.standard.go.kr) ： ：2005 3 31 ：2010 12 24 2010-0626 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS J 0014:2010 i ii iii 1 1 2 1 3 .1 4 SOP .2 4.1 2

2、4.2 SOP 3 4.3 SOP .4 4.4 SOP 5 5 .5 A( ) SOP 6 A.1 .6 A.2 SOP 6 B( ) SOP 7 B.1 (purpose) .8 B.2 (scope) .8 B.3 (reference documents).8 B.4 (definitions) .8 B.5 (responsivilities)8 B.6 (procedure) .8 B.7 11 KS J 0014:2010 ii . KS J 0014： 2005 . . , , . , , . KS J 0014:2010 iii 2005 KS J 0014 . . . ,

3、. KS J 0014:2010 Bioindustry Preparation of standard operating procedure and its application for bioindustrial process 1 . . 2 . . ( ) . KS A 0001, KS J 0001, 3 . KS J 0001 . 3.1 GMP (Good Manufacturing Practice)1) . 2) , . 3.2 SOP (Standard Operating Procedure) GMP . , SOP , SOP 1) 1969 (WHO) GMP ,

4、 , , GMP . GMP . 2) , , , , .KS J 0014:2010 2 . 3.3 QA (QA： Quality Assurance) , QA GMP . QA (QA ) . 3.4 QC (QC： Quality Control) , QC . QC (QC ) , QC , . 3.5 . . 3.6 GMP GMP . 4 SOP 4.1 4.1.1 1 ： (SOP No.) (Rev. No.) (Change control No.) (Prepared by) (Checked by) (Reviewed by) ( ) (Reviewed by) (Q

5、C ) (Reviewed by) (QA ) (Approved by) (GMP ) SOP . QA SOP (SOP No.) . KS J 0014:2010 3 SOP . Rev. 0 . QA (Change control No.) . , QA (effective date) . SOP ( , Rev. 0) . SOP . . 4.1.2 SOP 2 SOP (log sheet) Rev.0 . . Rev.1 1 . Rev. 4.1.3 SOP SOP . a) b) c) d) e) f) g) h) 4.2 SOP 4.2.1 . . 4.2.2 SOP .

6、 . 4.2.3 SOP SOP , SOP . KS J 0014:2010 4 4.2.4 . SOP . 4.2.5 SOP . QA SOP . , . 4.2.6 a) SOP , . , 3 , . b) SOP . c) , SOP . d) SOP , QC . 4.2.7 SOP . 4.2.8 , SOP , , (diagram) . 4.3 SOP 4.3.1 a) 4.1.3 . . . b) SOP (5W1H： , , , , , ) . c) SOP . d) SOP SOP . e) SOP . 4.3.2 SOP (4.2.6 ) . a) KS J 001

7、4:2010 5 b) , c) d) e) f) , g) h) 4.4 SOP QA SOP SOP (SOP No.) . 5 , . 3 SOP SOP /SOP (log book)/ QA QA / / KS J 0014:2010 6 A ( ) SOP A.1 SOP , . . A.2 SOP SOP ( ) ( ) ( ) SOP SOP No. Rev. No. ( SOP .) ： ( ) ( ) ： ( ) ( ) / ( ) C/C No. GMP ： ( ) ( ) A4(210 mm297 mm) KS J 0014:2010 7 B ( ) SOP Stand

8、ard Operating Procedure (SOP No.) . . . (Rev. No.) Rev. . . (Change control No.) . 5 1. 2/5 2. 2/5 3. 2/5 4. 2/5 5. 2/5 6. 2/5 7. 4/5 (Prepared by) (Checked by) (Reviewed by) ( ) (Reviewed by) (QC ) (Reviewed by) (QA (Approved by) (GMP ) Rev. 0 . . 2 Rev. 1 . . 1 KS (SOP No.) . . . (Rev. No.) Rev. .

9、 . (Change control No.) . 2/5 KS J 0014:2010 8 . a) . b) . c) , , , . d) . e) . B.1 (purpose) . B.2 (scope) . B.3 (reference documents) B.3.1 P&ID B.3.2 CIP SOP B.4 (definitions) B.4.1 CIP(Cleaning In Place) B.4.2 P&ID(Piping And Instrumentation Diagram) B.5 (responsivilities) B.5.1 , ( , ) . B.5.2

10、. B.6 (procedure) B.6.1 KS J 0014:2010 9 B.6.1.1 . B.6.1.2 (CLOSE) . B.6.1.3 (control loop) (STOP) . (RUN) . (SOP No.) . . . (Rev. No.) Rev. . . (Change control No.) . 3/5 B.6.1.4 PCV(Pressure Control Valve) (100 %) (OPEN) . B.6.2 (pre-washing) B.6.2.1 2 . B.6.2.2 HV23, HV29, HV30 . B.6.2.3 HV14, HV

11、13, HV11 (purified water) (spray ball) . B.6.2.4 . B.6.2.5 . B.6.2.6 HV11 . B.6.2.7 HV29, HV30 . B.6.2.8 . B.6.3 (CIP) 2 . B.6.3.1 B.6.3.1.1 MV31, HV10 , HV26, HV27 . B.6.3.1.2 CIP PU CIP1 CIP (： detergent) . B.6.3.1.3 CIP PU CIP2 CIP CIP . KS J 0014:2010 10 B.6.3.2 (air supply line) B.6.3.2.1 HV02

12、(CLOSE) HV08, HV09, HV12, HV05 (air sparger) CIP . B.6.3.3 (exhaust) B.6.3.3.1 FV(ventilation filter housing) . B.6.3.3.2 HV16 HV15 CIP . B.6.3.4 B.6.3.4.1 HV32, HV34, HV36 . B.6.3.4.2 HV35, HV39 ( 5 ) . B.6.3.5 B.6.3.5.1 HV40 , MV22 CIP . B.6.3.5.2 ( 5 ) CIP MV22 . B.6.3.5.3 ( 1 ) . B.6.3.5.4 PU CI

13、P1, PU CIP2 . B.6.3.5.5 MV31, HV10, HV27, HV39 CIP . B.6.3.5.6 . (SOP No.) . . . (Rev. No.) Rev. . . (Change control No.) . 4/5 B.6.4 (final PW rinse) . B.6.4.1 HV39 , HV25 . B.6.4.2 HV11 . B.6.4.3 B.6.3 (CIP) . , CIP . B.6.4.4 CIP PU CIP2 MV26 KS J 0014:2010 11 . B.6.4.5 HV02 (CLOSE) HV08, HV09, HV

14、12, HV05 (OPEN) (air sparger) . B.6.4.6 HV15 . B.6.4.7 HV32, HV34, HV36 . B.6.4.8 HV35, HV25 ( 5 ) . B.6.4.9 HV40 . B.6.4.10 ( ) . B.6.4.11 3). B.6.4.12 ( ) , HV11 . B.6.4.13 . B.6.5 B.6.5.1 MV01, HV01 . B.6.5.2 HV02, HV07 . B.6.5.3 ( 20 ) . B.6.5.4 . B.6.5.5 . B.6.5.6 . B.7 ( . ) . QA QA 5 ( ) 3) (

15、 . ) .KS J 0014:2010 12 (SOP No.) . . . (Rev. No.) Rev. . . (Change control No.) . 5/5 P&ID P&ID( . ) . MSGSGTCV-HTCV-CCoolingWaterCooling waterProcess AirTE04TICDrainPCVPFICPICCleaning solutionsupplyDrainCleaning solutionClean SteamCleaning solutionDrainClean steamPITVentDrainHarvest M/SBALL VALVEA

16、UTOMATIC VALVETHREE WAY VALVECONTROL VALVEDIAPHRAGMMAUNL VALVEPlant SteamCWSPMV03MV04MV05MV06MV16MV17MV23MV01MV02MV12MV13MV10MV25MV09HV01MV18MV19MV08HV02HV03HV04HV16HV17HV05HV07HV18HV22HV21HV38HV37HV28HV24HV23HV29HV36HV30HV32HV35HV34HV40HV10HV13HV20HV19Plant SteamHV08HV09HV26HV31SB30MV21MV22NIEEDIE

17、VALVESTEAM TRAPMV07HV42TE03TE06PUFGFVFGFVPUTESTSGGas FilterVent FilterPuMVTeMVeratureSight glassSteam trapTE02TE03FSIMV27MV28DrainInoculationBottlePH/HFPurified WaterHV11MV24HV33TE07HV14HV39MV15MV14HV15CIPtankMV25MV31PU-CIP1PU-CIP2MV26HV12LICLE01HV39W-1C-2S-1S-2MS-1C-3 C-4A-5A-1A-2A-4S-6W-3W-4S-7W-2

18、S-8C-6P-1S-10S-4C-6Transfer lineS-3P-2C-5S-9S-5C-1TE01FSB29SaMVleBottleHV25HV27HV06LICLE01MV20HV41 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS J 0014:2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS BioindustryPreparation of standard operating procedure and its application for bioindustrial processICS 07.080 Korean Agency for Technology and Standards http:/www.kats.go.kr