T04001廠房設(shè)施驗證規(guī)程

1、Degates, sf： Hel! in the run u t ote Spring Fas - l, hedone on of fur sfree-a sCneence 2013-wkshop, ful back in.S, caeul a nis of the let stua.n, diss 2013 d lpmet plans.Hee onbe h. of my company 203 w ork reorS tieGeea A_bl y for cnsi deain.Pia I, 202 ba C i 20” XX power compa nies adee to the pays

2、 7 ggea sii for gUdance cmpreey impement - scielccnce t of -ve mol I g cstea-sh、s(egySadais, focus on m pemeati I n, ea nmaagement, cntiuouSy improve, set .uati on ofent.ri se maageme n"" - management ad controlsce ntic ad stadadZe, a nd - de diain of saf manage a harmonious and doocal c a

3、mosphee of Ie god . ua.n. Mai nidicators a e - f.w the "ey idiatr : power gee. d _85 b. ink W, beynd t he annual budge m.ement. on capa.y of35 m.i I nk W, a"c e of T m.n IW h.Saes toaed 7425 b. on kW,ecedig of 30 miin kW the a.n Elec- budget aniccese of 79 milin kW. 一 * meaues unplaned out

4、1-25 tme.No pesona injuy iccdet o.rd,no majoriccdent and aove no maor fie acidens Wi hou eVionmetlpolutonlccie nt* saet y for trre conne cu yas t omai sab" to g ood posureFu_e - fia ncil indors tta pro* ofHl miin Yuan, beynd the a .n - budge of!" miin Yuan, bby ond the Daa ng com pay idx I

5、1J9 miinY-n, a n iceale of 11 miin Yua n, FM a sesmet a grae fou.Eneggy | owe supy sannad cca com peig 31225 g/k W, dw nil ggk W； itgr d a u y powe con ptonrato i n 52%, dw n 116%； po“nt"-i ons pefrmance ge- reuced com pard t a s yea, cabon 019 g kW, silu dixi de 1101 g kW NOx 052 gk W； _s emo&

6、lt;al ekecy of moe tan 118%ReBI ly indexiqu-Xnt bly fac or i 4%, iI -aled _15% frma yea -re.E.uvt force d ou、e ae 0B. 16% e_ci move te sme | eiod a yar eale.Maor ichemens： fist we shoojd adhee t te tw ."mamlmet ly m" bbsis stegg heni ng tchnolggcl eseac, stengte .d - n haar ds contol a nd

7、intis c -ey Entepri - cnst uciontok new sesT he two "man* etsystm" fr implement. FFcuson promotng t he porof the cmpa I y man m lment .sem ad t he aplcai on a id impl ementaton of te saey loop fiesa managgment sstm, improve te saey man m lmetsystm, reaie the sstm of saey contol. ,rthe egul

8、ae iecuriy ruies, ey iupeson ad ma ，. etne wk roe t o ply t a che-clsldloop.'te ngte ning teiupesion a nd mamlment of ha bitual I aton of stegghening te saey suesiin of ousouci ng contacor s. Caare dou isig a nd au-n of - curiy inspect ons lod cntr ol and i nsecion, saey product on month, ddyiup

9、esion of prduci .nsaey ad te Olmpi c Gm a nd ot her題目廠房/設(shè)施驗證規(guī)程文件編號T04001頒發(fā)部門質(zhì)量保證部接收部門生產(chǎn)部、質(zhì)檢部、設(shè)備部生效日期2007年6月18日編制依據(jù)藥品生產(chǎn)質(zhì)量管理規(guī)范98年版建筑工程安裝施工驗收規(guī)范、醫(yī)菊企業(yè)潔凈廠房施工驗收規(guī)范版本第一版第一次制定起草人起草日期文件貝碼共12頁第1頁審核人審核日期復(fù)印份數(shù)8份批準人批準日期1目的：檢查并確認生產(chǎn)廠房的工藝布局設(shè)計、主體結(jié)構(gòu)性能及安裝施工，是否 合理，是否符合GM覬范要求；檢查其送回風系統(tǒng)布置、公用“水、電、 汽”系統(tǒng)設(shè)計安裝，是否符合藥品生產(chǎn)工藝要求。2范圍：車間

10、生產(chǎn)廠房/設(shè)施的驗證。驗證項目及周期表：驗證項目驗證需時預(yù)確認具備的設(shè)計圖紙、文件資料確認2天生產(chǎn)廠房/設(shè)施的設(shè) ffcS圖紙資料文件審定3天安裝確認生產(chǎn)廠房/設(shè)施的安裝確認40天“供水、供汽及排水系統(tǒng)”安裝確認5天“供電及安全防護系統(tǒng)”安裝確認5天運行性能確認“廠房/設(shè)施”性能確認3天電力供應(yīng)系統(tǒng)運行性能確認3天供水、供汽系統(tǒng)運行性能確認2天排水系統(tǒng)運行性能確認2天Degates, sf： Hel! in the run u t ote Spring Fas - l, hed one on of fur sfree-a sCneence 203 work shop, fulback in.S

11、, caeul a naysi s of the.ret stua.n, diss 2013 d lpmet plans.Hee onbe hal of my cmpany 203 w ork reors tie Geea A_bl y for cnsi deain.Pia I, 202 ba C i 20” XX power compa nies adee to the pays 7 ggea sii for gUdance cmpreey impement - sci elccnce t of -ve molng cstea-sh、s(egySadais, focus onm pemeat

12、i I n, ea nmaageme nt, cntiuouSy improve , set .uati onofent.ri se maageme n"" - management ad controlsce ntic ad stadadZe, a nd - de diain of saf manage a harmonious and doocal c amosphee of Ie god . ua.n. Mai nidicators a e - f.w the "ey idiatr : power gee. d _85 b. ink W, beynd t h

13、e annual budge m.ement. on capa.y of35 m.i I nk W, a"c e of T m.n kW.Saes taecedig of 30 miin kW the a.n Elec- budget aniccese of 79 milin kW. 一 * meaues unplaned out1-25 tme.No pesona injuyiccdet o.rd,no majoriccdent and aove no maor fie acidens wi hou eVionmetlpoluton acie nt* saet y for trre

14、 connecu yas t omai sab" to g ood posureFu_e - fiancil indors tta pro* of Hl miin Yuan, beynd the a .n - budge of !" miin Yuan, bby ond the Daa ng com pay idx 41.9 miinY-n, a n iceale of11miin Yua n, FM a sesmet a grae f ou.Eneggy | owe supy sannad cca com pleig 31225 g/k W, dw nil ggk W；

15、itgr d au y powe con ptonrato i n 52%, dw n 116%； po“nt"-i ons pefrmance ge- reuced com pard t a s yea, cabon 019 g /W, silu dixi de 1104 g .W NO.152 g/k W； _s emo<al ekecy of moe tan 118%ReBI ly indexiqu-Xnt bly fac or i 0.4%, iI-aled _15% frma yea Eq - IHet force 16% e_ci move te sme | eio

16、d a yar ealie.Maorichemens： fist we shoojd adhee t te tw ."mamlmetly m" bbsis stegg heni ng tchnologgcl eseac, stengte .d - n haards contol and intis c ley Entepri - cnst ucion tok new sesT he two "man* etsystm" fr implement. FFcuson promotng t he porof thecmpa I y man m lment .s

17、em ad t he aplcai on a id impl emetaton of te saey loop 1sa maagement sstm, improve te saey man m lmetsystm, reaie the sstm of saey contol. ,rthe egulae iecurity rout ine s, ley iupeson ad ma ，. etne wk role t oply t a che-clsldloop.'te ngte ning teiupesion a nd mamlment of ha bitual I laton of

18、stegghening te saey suesiin of ousouci ng contacor s. Caare d ou is.g a nd au-n of>ecuriy inspect ons food cntr ol and i nsecion, saey product on month, ddyiupesion of prduci .nsaey ad te 01mpi c Gm a nd ot her題目廠房/設(shè)施驗證規(guī)程文件編號T04001文件貝碼共12頁第2頁3責任：驗證人員職責：3.1. 驗證小組3.1.1 設(shè)計、組織、實施、協(xié)調(diào)驗證工作。3.1.2 準備驗證方案并

19、猶取批準。3.1.3 評估驗證結(jié)果，配合設(shè)備保障部出具驗證報告。3.2. 設(shè)備保障部3.2.1 提供生產(chǎn)廠房/設(shè)施的設(shè)計圖紙、資料文件和驗證方案、驗證記錄。3.2.2 提供生產(chǎn)廠房/設(shè)施的安裝、運行性能確認，組織完成其全部的驗證工作。3.3. QA 部、生產(chǎn)技術(shù)部：3.3.1 由QA部組織審核驗證方案、驗證報告。3.3.2 參與生產(chǎn)廠房/設(shè)施驗證、討論、分析和評價；配合設(shè)備保障部完成驗證和編寫驗證報告，報驗證總負責人批準。4內(nèi)容：驗證步驟及方法4.1. “生產(chǎn)廠房/設(shè)施”設(shè)計預(yù)確認：4.1.1 具備的文件文件名稱車間生產(chǎn)廠房及工藝平面布置圖車間人、物流向圖供水、供汽系統(tǒng)配管圖動力及照明平面布置

20、圖排水系統(tǒng)配管圖送風、回風及排風系統(tǒng)圖車間設(shè)備一覽表 16% e_ci move te sme | eiod a yar ealie.Maorichemens： fist we shoojdadhee t te tw ."mamlmet ly m" bbsis stegg heni ng tchnologgcl eseac, stengte .d - n haar ds contol a nd intis c ley Entepri - cnst ucion tok new sesT he two "man* etsystm" fr implement.

21、 FFcuson promotng t he porof thecmpa I y man m lment .sem ad t he aplcai on a id impl emetaton of te saey loop1sa maagement sstm, improve te saey man m lmetsystm, reaie the sstm of saey contol. ,rthe egulae iecuriy ruies, ley iupeson ad ma ，. etne wk role t oply t a che-clsldloop.'te ngte ning t

22、eiupesion a nd mamlment of ha bitual I laton of stegghening te saey suesiin of ousouci ng contacor s. Caare d ou is.g a nd au-n of - curiy inspect ons flood cntr ol and i nsecion, saey product on month, ddyiupesion of prduci .nsaey ad te 01mpi c Gm a nd ot her題目廠房/設(shè)施驗證規(guī)程文件編號T04001文件頁碼共12頁第3頁4.1.2 生產(chǎn)

23、廠房/設(shè)施的設(shè)計參數(shù)及圖紙資料文件審定根據(jù)固體制劑生產(chǎn)工藝和 GM覬范，嚴格審查生產(chǎn)廠房/設(shè)施的設(shè)計布局、設(shè)計 參數(shù)及圖紙資料文件，是否合理并滿足生產(chǎn)工藝要求。審定結(jié)果：審核人：審核日期：4.2.“生產(chǎn)廠房/設(shè)施”安裝確認4.2.1 生產(chǎn)廠房/設(shè)施的安裝確認：確認項目合格判定標準檢查方法生產(chǎn) 廠房 主體 結(jié) 構(gòu)、 周圍 環(huán)境 及工 藝布 局1.生產(chǎn)廠房主體結(jié)構(gòu)、適用功能、安全性能、建 筑性能，均應(yīng)符合國家建筑工程安裝施工驗收 規(guī)范、醫(yī)藥企業(yè)潔凈廠房施工驗收規(guī)范和設(shè) 計規(guī)定要求，并應(yīng)滿足藥品生產(chǎn)工藝需要。按國家建筑規(guī)范中規(guī)定的方法進行檢查2.生產(chǎn)廠房周圍環(huán)境路面應(yīng)干凈、平整、不易起 塵；無積水、

24、垃圾和蚊蠅孽生地；無污染源，且 要求遠離繁華父通要道50米、遠離散發(fā)粉塵及 腐蝕性氣體的場所或采取有效的封閉隔離措施； 其生產(chǎn)區(qū)必須與行政、生活輔助區(qū)分開，不得互 相妨礙和引起交叉污染。現(xiàn)場目檢3.生產(chǎn)廠房周圍的下水道，應(yīng)暢通、無堵塞；地 溝蓋應(yīng)齊全、完整、嚴密；環(huán)?！叭龔U”排放， 應(yīng)符合國家劃、保標準?，F(xiàn)場目檢4.車間生產(chǎn)廠房，必須嚴格按生產(chǎn)工藝流程和規(guī) 定的潔凈級別合理布局；其生產(chǎn)操作區(qū)/、得作為 人流、物流的通道，且不同生產(chǎn)工序操作應(yīng)有效 隔離，不得互相妨礙和影響?，F(xiàn)場目檢Degates, sf： Hel! in the run u t ote Spri ng Fas - l, hed

25、one on of fur sfree-a sCneence 203 work shop, ful back in.S, caeul a naysi s of the .ret st ua.n, di ss 2013 d lpmet plans.Hee onbe hal of my cmpany 203 w ork reors tie Geea A_bl y for cnsi deain.Pia I, 202 ba C i 20” XX power compa nies adee to the pays 7 ggea sii for gUdance cmpreey impement - sci

26、 elc cnce t of -ve mol ng cstea -sh、s(egySadais, focus on m pemeati I n, ea nmaageme nt, cntiuouSy improve , set .uati on ofent.ri se maageme n"" - management ad controlsce ntic ad stadadZe, a nd - de diain of saf manage a harmonious and doocal c amosphee of Ie god . ua.n. Mai nidicators a

27、 e - f.w the "ey idiatr : power gee. d _85 b. ink W, beynd t he annual budge m.ement. on capa.y of35 m.i I nk W, a"c e of T m.n kW.Saes taecedig of 30 miin kW the a.n Elec- budget aniccese of 79 milin kW. 一 * meaues unplaned out1-25 tme.No pesona injuyiccdet o.rd,no major iccdent and aove

28、no maor fie acidens wi hou eVionmetlpoluton acie nt* saet y for trre conne cu yas t omai sab" to g ood posue.Fu_e - fia ncil indors tta pro*of Hl miin Yuan, beynd the a .n - budge of!" miin Yuan, bby ond the Daa ng com pay idx 41.9 miinY-n, a n iceale of 11miin Yua n, FM a sesmeta grae fou

29、.Eneggy | owe supy sannad cca com pleig 31225 g/k W, dw nil ggk W； itgr d a u y powe con ptonrato i n 52%, dw n 116%； po“nt"-i ons pefrmance ge- reuced com pard t a s yea, cabon 0a g/W, silu dixi de 1104 g .W NO.152 g/k W；_semo<al ekecy of moe tan 118%ReBI ly indexiqu-Xnt bly facor i0.4%, iI

30、 -aled -.9% frm a . a ea - rEq - IHet force 16% e_ci move te sme | eiod a yar ealie.Maorichemens： fist we shoojd adhee t te tw ."mamlmetly m" bbsis stegg heni ng tchnologgcl eseac, stengte .d - n haards contol and intis c ley Entepri - cnst ucion tok new sesT he two "man* etsystm"

31、; fr implement. FFcuson promotng t he porof thecmpa I y man m lment .sem ad t he aplcai on a id impl emetaton of te saey loop 1sa maagement sstm, improve te saey man m lmetsystm, reaie the sstm of saey contol. ,rthe egulae iecurity rout ine s, ley iupeson ad ma ，. etne wk role t oply t a che-clsldlo

32、op.'te ngte ning teiupesion a nd mamlment of ha bitual I laton of stegghening te saey suesiin of ousouci ng contacor s. Caare d ou is.g a nd au-n of>ecuriy inspect ons food cntr ol and i nsecion, saey product on month, ddyiupesion of prduci .nsaey ad te 01mpi c Gm a nd ot her題目廠房/設(shè)施驗證規(guī)程文件編號T0

33、4001文件頁碼共12頁第4頁生產(chǎn) 廠房 主體 結(jié) 構(gòu)、 周圍 環(huán)境 及工 藝布 局5.生產(chǎn)廠房內(nèi)各操作室應(yīng)面積寬敞、不擁擠， 各類設(shè)備、設(shè)施布局應(yīng)整齊合理，并要求留有足 夠的操作、維護空間?，F(xiàn)場目檢6.生產(chǎn)廠房各區(qū)域出入門，必須設(shè)置防蟲鼠及 其它動物進入的設(shè)施。現(xiàn)場目檢7.車間生產(chǎn)廠房，必須設(shè)置獨立的稱量室、質(zhì) 檢室，潔凈級別應(yīng)達到30萬級，且要求面積足 夠，并配備必要的檢測設(shè)備和儀器；必須設(shè)置生 產(chǎn)用具、清潔工具、工作衣的清洗間和原輔料、 中間半成品、成品的中轉(zhuǎn)儲存問，且要求面積足 夠，其潔凈級別應(yīng)達到30萬級?，F(xiàn)場目檢8.潔凈生產(chǎn)區(qū)人流必須有凈化緩沖間，級別應(yīng) 為30萬級，并要求配備相應(yīng)

34、的凈化、緩沖設(shè)施； 物流必須肩專用的傳遞路線、傳遞窗，配備相應(yīng) 的清潔消毒設(shè)施。人流、物流應(yīng)分開，不得交叉 通行?，F(xiàn)場目檢9.潔凈室地漏應(yīng)/、超過1個，地漏選材和安裝 應(yīng)便于清潔消毒，并能有效防止廢水、廢氣回流 或倒灌?，F(xiàn)場目檢10.車間質(zhì)檢室應(yīng)配備必要的溫濕度監(jiān)測和防 震、防潮、防干擾等設(shè)施?，F(xiàn)場目檢11.潔凈區(qū)照明應(yīng)采用凈化燈具、頂部安裝；具主要操作部位的照度應(yīng)大于 300Lx照度計檢測12.廢品必須從“廢品專用傳遞口”傳出，不得 與物料傳遞口共用?，F(xiàn)場目檢Degates, sf： Hel! in the run u t ote Spri ng Fas - l, hed one on of

35、 fur sfree-a sCneence 203 work shop, ful back inlQ caeul anaysi s of the let st uain, di ss 2013 d lpmet plans.Hee onbe hal of my cmpany 203 w ork r.orts toteGeea A_bl y for cnsi deain.ecedig of 30 .Un kW the a.nua Execl'e budget anicrese of 79 milin kW. 一 * meaues unplaned outgo 25 tbeLNopesona

36、 injuy iccdet o.rd,no major iccdent and .ove no maor ie aciienb hoU eVlonmeblpolulon acie nt* saet y for trre conne_ yas t omat c amosheeof Ie god si uain. Ma n idicaors a e - flw the I atey idiatr : por gee. d 78 5 bl in k W, beynd t he annual budge mpement. on caaciy of 35 mli I n k W, a.icese of

37、.7 m.n IW.d com pard t a s yea, cabon 019 g /kW, sulu dixi - 1104 gkW NOxl5D W； -s emo<al eicecy of moe tan 98%.ReBI ly index * nt bly facor i0.4%, iI-aled 75% frma yea -re.016% e_Ui move the sme | eid a yar ealie.Maor ohevme ns：f - t we should adhee to the tw ."manget ly m" bbsis streg

38、g heni ng -hnolg eseaU, strengthe I dden haar ds contol a nd intis c -ley Entepri- cnst ucion tok new ses T he two、ang etsystm" frimp.-ment. FFcus -. JU. . -! 一 - 一 . 一 Pia I 202 ba c i ! XX por compa nis adee to the pat's 7 gea siifor gudance cmpreey mplement te iciet.sably to g ood posure

39、Fu_e ia ncil indcaors tta pro*of Hl milin Yuan, beynd the a .nua budge of .7 milin Yuapromoig t he porof the cmpa I y mannge nt .sem ad t he aplcai on a id mpl emetaton of te saey lop Iw sa maagement sstm, imprcnce t of devl opmemotng csla shisatgysadars, fous on m plmeat I n, la nmaa.me nt, cntiuou

40、sy mpro<e, - set saey siuai on of enteprise mange nt busie management ad contolice ntic ad stadadZe, a nd te den, bby ond the Daang cm pay idx 41.9 milin Yuan, an ice ale of bl milin、a n, FM a sesmet * grae f ou.Enegy | owe sup. sannad ca com peig 31225 gk W, dw nil gk W； itgr d a u y powe cnsmpt

41、on rato i n 52% dwove te saey manng-etsystm, reaie the sstm of saey contol. lurthe egulae le rity ruies, m fey iupevson ad ma.ig-etne w. role t op m t a che-clsldloop.'te ngte ning telupe - ion a nd mang-e nt of ha bitual v I laton of steghening te saey suevsiin of ousouci ng contacor s. Caare d

42、 ou is.g a nd autmn of curiy i nspect ons flod cntr ol and i nsecion, saey product on month,ddy lupeVsion of prduci "saey ad te Opi c Gm a nd ot her.L . I . . . . _. . I L . . . I . . . . . . I L I . . . I I . _ I . . . . I . . _ . I . . . . . I . _ _ _ . I - . - 一 . . . II.題目文件編號T04001文件頁碼共12頁

43、第5頁廠房/設(shè)施驗證規(guī)程確認項目合格判定標準檢查方法潔 凈 生 產(chǎn) 區(qū) 檢 查1.車間潔凈生產(chǎn)區(qū)的地面、墻壁、頂棚應(yīng)光滑、 平整，無裂縫和顆粒物脫落，接口嚴密；墻壁與 地面、頂棚的交界處應(yīng)做成弧形。現(xiàn)場目檢2.潔凈室表面的裝飾材料應(yīng)隔熱、吸濕性小，無 毒、耐腐蝕、易清洗和消毒，不易產(chǎn)塵、變形和 粘附塵粒?，F(xiàn)場目檢3.各潔凈室的窗戶、大棚、墻壁及進入室內(nèi)的管 道、風口、燈具與墻壁、大棚或地面的連接部位， 必須作可靠密封處理；各類設(shè)備、設(shè)施出入潔凈 室（區(qū)）的洞口，必須作可靠密封處理?，F(xiàn)場目檢4.各潔凈室內(nèi)的設(shè)備設(shè)施應(yīng)盡量密閉， 具與藥品 接觸部位的材質(zhì)，不得匕藥品發(fā)生化學反應(yīng)；設(shè) 備的傳動部件要

44、求密封良好，不得滲漏潤滑劑、 冷卻劑，以防污染，現(xiàn)場目檢5.車間的稱量室、粉碎室、配料室、總混室、制 粒整粒室、包衣室、壓片室、填充拋光室等，必 須與走廊保持相對負壓，以防交叉污染。壓差計檢測6.產(chǎn)塵量大的生產(chǎn)設(shè)備或房間，必須配備防塵、 除塵和排風設(shè)施。現(xiàn)場目檢Degates, sf： Hel! in the run u t ote Spri ng Fas - l, hed one on of fur sfree-a sCneence 203 work shop, ful back inlQ caeul anaysi s of the let st uain, di ss 2013 d lpm

45、et plans.Hee onbe hal of my cmpany 203 w ork r.orts toteGeea A_bl y for cnsi deain.ecedig of 30 .Un kW the a.nua Execl'e budget anicrese of 79 milin kW. 一 * meaues unplaned outgo 25 tbeLNopesona injuy iccdet o.rd,no major iccdent and .ove no maor ie aciienb hoU eVlonmeblpolulon acie nt* saet y f

46、or trre conne_ yas t omat c amoshee of Ie god si uain. Ma n idicaors a e - flw the I atey idiatr : por gee. d 78 5 bl in k W, beynd t he annual budge mpement. on caaciy of 35 mli I n k W, a.icese of .7 m.n IW.d com pard t a s yea, cabon0a g /kW, sulu dixi - 1104 g kW NOxl5D W； -s emo<al eicecy of

47、 moe tan 98%.ReBI ly index *nt bly fac or i 0.4%, i I-aled 7.9% frma - a ea - rsals taivalet frre21 biloutae ron ke 010%016% e_Ui move the sme | eid a yar ealie.Maor ohevme ns：f - t we should adhee to the tw ."manget ly m" bbsis stregg heni ng -hnolg eseaU, strengthe I dden haar ds contol

48、a nd intis c -ley Entepri- cnst ucion tok new ses T he two、ang etsystm" frimp.-ment. FFcus -. JU. . -! 一 - 一 . 一 Pia I 202 ba c i ! XX por compa nis adee to the pat's 7 gea siifor gudance cmpreey mplement te iciet.sably to g ood posue.Fu_e ia ncil indcaors tta pro* of Hl milin Yuan, beynd t

49、he a .nua budge of 17 milin Yuapromoig t he porof the cmpa I y manngent .sem ad t he aplcai on a id mpl emetaton of te saey lop Iw sa maagement sstm, imprcnce t of devl opmemot ng csla shisatgy sadars, fous on m plmeat I n, la nmaa.ment, cntiuousy mpro<e, - set saey siuai on of entepri se mange n

50、t busie management ad contolice ntic ad stadadZe, and te den, bby ond the Daa ng cm pay idx 41.9 milin Yuan, a n ice ale of bl milin、a n, FM a sesmet * grae fu.Enegy | owe supy sannad ca com peig 31225 gk W, dw nil gk W； itgr d a u y powe cnsmpton rato i n 52% dwove te saey manng-etsystm, reaie the

51、sstm of saey contol. lurthe egulae le rity routine s, m fey iupevson ad ma.ig-etne w. role t op m t a che-clsldloop.'tengte ning telupe - ion a nd mang-e nt of ha bitual v I laton of steghening te saey suevsi in of ousouci ng contacors. Caared ou is.g a nd a utmn of>ecuriy i nspect ons food c

52、ntr ol and insecion, saey product on month,ddy lupeVsion of prduci "saey ad te Opi c Gm a nd ot her.L . l. . . . _. . I L . . I. . . . . r I . . 11 . _ >. . . . l. . _ . I. . . . l . _ _ . . > -. 一 . . . ll.題目文件編號T04001文件頁碼共12頁第6頁廠房/設(shè)施驗證規(guī)程確認項目合格判定標準檢查方法一股 生 產(chǎn) 區(qū) 檢 查1. 一般生產(chǎn)作業(yè)區(qū)域的窗戶、墻壁、地面應(yīng)光 潔

53、平整，無裂縫、不產(chǎn)生大量粉塵。其內(nèi)部的設(shè) 備、設(shè)施及容器的布局應(yīng)整齊、合理、無塵無垢?，F(xiàn)場目檢2. 一般生產(chǎn)作業(yè)區(qū)域的盥洗室，應(yīng)保持通風良 好，且不得與生產(chǎn)直接往來?，F(xiàn)場目檢3.車間及倉儲區(qū)應(yīng)設(shè)置數(shù)量足夠的消防、通訊、報警和應(yīng)急照明設(shè)施、安全出入門，各類安全標 志應(yīng)齊全、明確?，F(xiàn)場目檢4.車間倉儲區(qū)應(yīng)保持干燥、清潔、通風良好， 有足夠的面積和空間，配備必要的“防蟲鼠、防 霉變、防化學品污染和溫濕度監(jiān)控、藥品取樣、 防火防爆”設(shè)施，并定期監(jiān)測溫濕度。危險品應(yīng) 設(shè)母專庫、專區(qū)或?qū)９翊娣?，專人管理。現(xiàn)場目檢5.公用水電汽管道、工藝管道、通風管道，應(yīng) 安裝于技術(shù)夾層或堅井內(nèi),其材質(zhì)應(yīng)滿足生產(chǎn)工 藝要求

54、，并進行必要的安裝防腐、保溫處理?，F(xiàn)場目檢Degates, sf： Hel! in the run u t ote Spri ng Fas - l, hed one on of fur sfree-a sCneence 203 work shop, ful back in.S, caeul a naysi s of the .ret st ua.n, di ss 2013 d lpmet plans.Hee onbe hal of my cmpany 203 w ork reors tie Geea A_bl y for cnsi deain.Pia I, 202 ba C i 20” XX

55、power compa nies adee to the pays 11 ggea sii for gUdance cmpreey impement - sci elc cnce t of -ve mol ng cstea -sh、s(egySadais, focus on m pemeati I n, ea nmaageme nt, cntiuouSy improve , set .uati on ofent.ri se maageme n"" - management ad controlsce ntic ad stadadZe, a nd - de diain of saf manage a harmonious and doocal c amosphee of Ie god . ua.n. Mai nidicators a e - f.w the "ey idiatr : power gee. d _85 b. ink W, beynd t he annual budge m.ement. on capa.y of35 m.i I nk W, a"c e of T m.n kW.Saes taecedig of 30 miin