歐盟CGMP清潔驗(yàn)證方案1.doc

XXXX片（10mg規(guī)格）清潔驗(yàn)證方案Cleaning Validation Protocol of XXXX Tablets(10mg)方案起草Prepared by部門(mén)/崗位Dept./Position簽名Signature起草日期DateQA年(Y) 月(M) 日(D)方案審核Reviewed by部門(mén)/崗位Dept./Position簽名Signature審核日期DateQC主管QC Supervisor年(Y) 月(M) 日(D)QA主管QA Supervisor年(Y) 月(M) 日(D)方案批準(zhǔn)Approved by部門(mén)/崗位Dept./Position簽名Signature批準(zhǔn)日期Date質(zhì)量保證部經(jīng)理QA Manager 年(Y) 月(M) 日(D)頒發(fā)部門(mén)Issued byQA生效日期：Effective Date分發(fā)部門(mén)Distributed to 制造部（1份）、QC（1份）Production Dept.(1 copy), QC (1 copy)制作備份：2份Copies prepared:2 pcs.目 錄 Table of Contents1.清潔驗(yàn)證小組人員名單/Team Member List32.概述/General Introduction42.1本產(chǎn)品生產(chǎn)中使用的設(shè)備/Equipments used in the manufacturing42.2本產(chǎn)品生產(chǎn)中使用的容器具52.2Utensils used in the manufacturing52.3本產(chǎn)品生產(chǎn)中使用的設(shè)備主要材質(zhì)52.3Construction materials contacting with drug product53.清潔驗(yàn)證目的/Purpose of cleaning validation54.職責(zé)/Responsibility64.1制造部/Production Dept.64.2質(zhì)量保證部/QA Dept.64.3設(shè)備動(dòng)力部/Engineering Dept.75.方案的執(zhí)行/Execution of protocol85.1記錄填寫(xiě)要求/Filling of Raw Data85.2偏差、OOS/OOT的調(diào)/Deviation, OOS/OOT investigation85.3方案改變的控制程序/Change Control86.清潔驗(yàn)證內(nèi)容Content of cleaning validation96.1清潔驗(yàn)證的準(zhǔn)備工作Preparation before cleaning validation96.2XXXX殘留限度標(biāo)準(zhǔn)的設(shè)定/Criteria of residual limit136.3取樣程序及取樣方法/Sampling procedure and method146.4清潔驗(yàn)證過(guò)程/The process of cleaning validation206.5完成此清潔驗(yàn)證方案的所有人員身份資質(zhì)的確認(rèn)226.5 Identification of Personnel Executing this Protocol227.附件及索引Attachments and index238. 培訓(xùn)記錄/Training Records24附件一 制造部及QC本次清潔確認(rèn)過(guò)程中所有使用的設(shè)備、儀器、儀表、計(jì)量器具等確認(rèn)或校驗(yàn)情況總結(jié)表26Attachment 1: list of verification for production equipments & QC instruments26附件二：取樣位置示意圖28Attachment 2 Schematic diagram for sampling locations28附件三：QC化學(xué)檢測(cè)取樣記錄表41Attachment 3 Sampling record form for QC chemical testing41附件四：QC化學(xué)檢測(cè)結(jié)果匯總表47Attachment 4 Summary table for QC chemical testing results47附件五：QC微生物檢測(cè)取樣記錄表53Attachment 5 Sampling record form for QC Microbial testing53附件六：QC微生物檢測(cè)結(jié)果匯總表62Attachment 6 Summary table for QC microbial testing results621.清潔驗(yàn)證小組人員名單/Team Member List組 長(zhǎng) Team Leader部門(mén) Dept.崗位 Position姓名 Name制造部 Production Dept.業(yè)務(wù)經(jīng)理 Supervisor小組成員 Team Member部門(mén) Dept.崗位 Position姓名 Name設(shè)備動(dòng)力部 Engineering Dept.業(yè)務(wù)經(jīng)理 Supervisor制造部 Production Dept.工藝質(zhì)量員 Technician制造部 Production Dept.生產(chǎn)協(xié)調(diào)員 Production Coordinator制造部 Production Dept.工藝質(zhì)量員Production Coordinator制造部 Production Dept.工段長(zhǎng) Team leader制造部 Production Dept.技術(shù)員 Technician制造部 Production Dept.工段長(zhǎng) Team leader制造部 Production Dept.技術(shù)員Technician制造部 Production Dept.工段長(zhǎng) Team leader制造部 Production Dept.技術(shù)員Technician制造部 Production Dept.工段長(zhǎng) Team leader制造部 Production Dept.技術(shù)員 Technician制造部 Production Dept.工段長(zhǎng) Team leader制造部 Production Dept.技術(shù)員TechnicianQCQC主管 QC SupervisorQC理化1組組長(zhǎng)Leader of physicochemical team 1QC微生物組組長(zhǎng)Leader of Microbial teamQC微生物檢驗(yàn)員AnalyzerQAQA檢查員 QA inspectorQAQA檢查員 QA inspectorQAQA檢查員 QA inspectorQA驗(yàn)證管理員Validation administrator2.概述/General Introduction根據(jù)GMP的要求，在口服固體制劑生產(chǎn)結(jié)束后，要對(duì)生產(chǎn)設(shè)備及操作間進(jìn)行徹底清潔，以避免造成不同批號(hào)或不同品種產(chǎn)品之間的污染和交叉污染。根據(jù)各生產(chǎn)設(shè)備的操作、清潔及維護(hù)保養(yǎng)標(biāo)準(zhǔn)操作規(guī)程，將清潔方法分為水溶性及非水溶性兩組，XXX屬于水溶性組。為了驗(yàn)證清潔方法的穩(wěn)定性與可靠性，在進(jìn)行該產(chǎn)品10mg規(guī)格工藝驗(yàn)證的同時(shí)進(jìn)行三次清潔驗(yàn)證。10mg規(guī)格每批生產(chǎn)結(jié)束后，對(duì)所有在生產(chǎn)中使用的生產(chǎn)設(shè)備及容器具進(jìn)行清潔，清潔后取樣檢測(cè)化學(xué)殘留及微生物殘留，要求殘留量低于設(shè)定的殘留限度要求。因配料階段原料不進(jìn)行篩分，稱重后放入塑料袋內(nèi)再放入中轉(zhuǎn)筒中儲(chǔ)存，所以配料階段清潔后只對(duì)接觸原料的料鏟進(jìn)行化學(xué)及微生物取樣，其它部位只進(jìn)行微生物取樣。According to requirements of GMP, the manufacturing equipments and rooms must be completely cleaned to avoid contamination of different batches of same products or cross-contamination of different products after manufacturing of oral solid dosage. There are two types of cleaning method based on SOPs of Operation/ Cleaning and maintenance for individual equipments: Water-cleaning method and non-water-cleaning method. The cleaning method for XXX belongs to the former. Three consecutive cleaning validation will be conducted synchronously during process validation of 10mg strength Tablets to validate the stability and reliability of cleaning method on the basis of finishing cleaning verification of trial batch. All equipments and utensils used in manufacturing must be completely cleaned once every batch of 10mg XXXX Tablets is finished, then sample to test chemical residual and microbial residual, the requirement is the level of residual is less than the limit of residual. Because API is not sieved during dispensing phase and directly put into a bag within a transferring container, only spoon contacting with API will be tested for chemical and microbial items, while other parts are only tested for microbial items.2.1本產(chǎn)品生產(chǎn)中使用的設(shè)備/Equipments used in the manufacturing列出本產(chǎn)品生產(chǎn)中所使用的所有設(shè)備List all equipments used in this product.2.2本產(chǎn)品生產(chǎn)中使用的容器具Utensils used in the manufacturing料倉(cāng)、中轉(zhuǎn)桶、料鏟Bin, Transferring container and spoon.2.3本產(chǎn)品生產(chǎn)中使用的設(shè)備主要材質(zhì)Construction materials contacting with drug product與藥品接觸的部位材質(zhì)為304或316L不銹鋼；鑄鐵；玻璃等。 Construction materials contacting with drug product is 304 or 316L stainless steel, cast iron or glass, etc.3.清潔驗(yàn)證目的/Purpose of cleaning validation驗(yàn)證制定的清潔程序可以使XXX的殘留量及微生物殘留量符合制定的殘留限度的要求，清潔后的設(shè)備及容器具可以再次投入使用。The pre-determined cleaning methods will be validated that these methods can effectively remove residual and satisfy the limit for chemical residual and microbial residual. The equipments and utensils which are cleaned by this method can be reused again.4.職責(zé)/Responsibility4.1制造部/Production Dept.組織清潔驗(yàn)證方案及報(bào)告的起草；Prepare the cleaning validation protocol/report確定設(shè)備表面積、清潔方法、取樣部位；Determine the surface area of equipments, cleaning method and sampling locations制定清潔操作規(guī)程；Establish cleaning procedure按清潔操作規(guī)程清潔設(shè)備和容器具；Clean equipments and utensils according to cleaning procedure確保清潔記錄填寫(xiě)完整；Make sure the completeness of cleaning records將完成的清潔驗(yàn)證文件提交給QA審查；Submit the finalized cleaning documentation to QA review4.2質(zhì)量保證部/QA Dept. QC審核清潔驗(yàn)證方案/報(bào)告；Review the cleaning validation protocol/report 制定清潔驗(yàn)證取樣方法和檢測(cè)方法； Establish sampling method and analytical method of cleaning validation對(duì)清潔后設(shè)備、容器具進(jìn)行取樣和檢測(cè)，報(bào)告檢驗(yàn)結(jié)果；Sample and test cleaned equipments and utensils, then report the testing results.使用在校驗(yàn)有效期內(nèi)的儀器設(shè)備進(jìn)行檢測(cè)。 Use those instruments within calibration expired dateQA制定清潔驗(yàn)證計(jì)劃及驗(yàn)證編號(hào)；Establish cleaning validation plan and No.負(fù)責(zé)組織審核清潔驗(yàn)證的方案/報(bào)告；Organize the review the cleaning validation protocol/report組織清潔驗(yàn)證相關(guān)部門(mén)進(jìn)行清潔驗(yàn)證方案的培訓(xùn)并記錄；Organize the training and record for cleaning validation protocol 負(fù)責(zé)驗(yàn)證實(shí)施過(guò)程的協(xié)調(diào)，保證驗(yàn)證項(xiàng)目實(shí)施進(jìn)度；Coordinate the activities of cleaning validation to ensure the performance.驗(yàn)證實(shí)施中的監(jiān)控檢查；Supervise the validation activities.保證經(jīng)驗(yàn)證的參數(shù)符合預(yù)期的標(biāo)準(zhǔn)；Make sure validated parameters meet pre-determined criteria負(fù)責(zé)組織驗(yàn)證方案中改變控制、偏差處理的調(diào)查；Organize the investigation for the change control and deviation handling.負(fù)責(zé)將完成的清潔驗(yàn)證文件歸檔。Archive the completed cleaning validation documentation質(zhì)量保證部經(jīng)理：QA Manager批準(zhǔn)清潔驗(yàn)證方案、驗(yàn)證報(bào)告。Approve the cleaning validation protocol and report4.3設(shè)備動(dòng)力部/Engineering Dept.保證清潔驗(yàn)證過(guò)程中，所用到的儀器儀表在校驗(yàn)有效期內(nèi)；Ensure the instruments and meters involved in the cleaning validation have been calibrated and within calibration due date.保證驗(yàn)證過(guò)程中空調(diào)、純化水、壓縮空氣、熱水等的供應(yīng)，確保清潔驗(yàn)證的實(shí)施。Ensure the normal working order and operation of HVAC, purified water system, compressed air, hot water for the cleaning validation.5.方案的執(zhí)行/Execution of protocol5.1記錄填寫(xiě)要求/Filling of Raw Data 所有清潔驗(yàn)證取樣記錄、檢驗(yàn)結(jié)果應(yīng)記錄在批準(zhǔn)過(guò)的方案的相應(yīng)記錄表格內(nèi)；All sampling records and testing results related cleaning validation should be filled in the corresponding tables within approved validation protocol.記錄、數(shù)據(jù)的填寫(xiě)、計(jì)算應(yīng)審核并簽字；Entry and calculation of raw data should be reviewed and signedQA應(yīng)檢查清潔驗(yàn)證數(shù)據(jù)記錄是否完整、是否符合規(guī)定。QA should check the completeness of data records and make sure whether they are satisfied related requirements.5.2偏差、OOS/OOT的調(diào)/Deviation, OOS/OOT investigation當(dāng)檢測(cè)結(jié)果異常時(shí)，按照檢驗(yàn)結(jié)果超標(biāo)情況的處理文件編號(hào)XXX的操作規(guī)程執(zhí)行。When the testing results are abnormal, follow the SOP the handling of out of specifications (Doc. No.:XXX) to investigate.當(dāng)出現(xiàn)操作不符合SOP要求時(shí)，執(zhí)行部門(mén)應(yīng)通知QA，執(zhí)行偏差調(diào)查。清楚地描述該偏差的情況、記錄文件、對(duì)于偏差的影響的評(píng)估并經(jīng)過(guò)批準(zhǔn)、解決偏差所需采取的行動(dòng)措施。偏差的調(diào)查應(yīng)按照SOP偏差的處理文件編號(hào)XXX執(zhí)行。When the operations dont meet the requirements specified in SOPs, the associated dept. should notify QA to make deviation investigation. It is required to describe the deviation occurance clearly and make reords. The evaluation focusing on the potential influence from the deviations should be done and the corrective actions must be approved. The deviation investigation should follow the SOP the handling of deviation (Doc. No.:XXX).5.3方案改變的控制程序/Change Control 當(dāng)方案在執(zhí)行的過(guò)程中，出現(xiàn)既定的內(nèi)容或要求與實(shí)際執(zhí)行情況或清潔驗(yàn)證的目的不一致，需要對(duì)原批準(zhǔn)方案進(jìn)行改變，執(zhí)行部門(mén)應(yīng)按照改變控制文件編號(hào)SOP-XXX的操作規(guī)程執(zhí)行。 During implementing the protocol, when there happens some variance between the procedures specified in the protocol and actual situation or the purpose of validation and the approved protocol is in need of change, follow the SOP change control(Doc. No.: SOP-XXX).6.清潔驗(yàn)證內(nèi)容Content of cleaning validation6.1清潔驗(yàn)證的準(zhǔn)備工作Preparation before cleaning validation6.1.1進(jìn)行生產(chǎn)設(shè)備清潔驗(yàn)證前，所有與清潔驗(yàn)證有關(guān)的儀器、設(shè)備應(yīng)進(jìn)行過(guò)校驗(yàn)或確認(rèn)。儀表、計(jì)量器具等應(yīng)校驗(yàn)合格，儀器、設(shè)備等應(yīng)建立相應(yīng)的操作、維護(hù)保養(yǎng)規(guī)程，對(duì)清潔驗(yàn)證的樣品應(yīng)建立相應(yīng)的檢驗(yàn)操作規(guī)程。本次清潔驗(yàn)證中制造部生產(chǎn)過(guò)程中所使用設(shè)備的確認(rèn)情況及QC檢驗(yàn)過(guò)程中所使用的儀器、設(shè)備、儀表、計(jì)量器具等確認(rèn)或校驗(yàn)情況見(jiàn)附件一。 Before implementing the cleaning validation protocol, all instruments and equipments related to cleaning validation should be calibrated or verified. Instruments and gauges should be calibrated and within the calibration due date, instruments and equipments should have been established corresponding operation and maintenance procedure, and sample for cleaning validation have been established testing procedure. Attachment 1 is list of verification for equipments used in the manufacturing and instruments, equipments and gauges used in QC Lab.6.1.2清潔驗(yàn)證所需的試驗(yàn)條件/Testing condition needed for cleaning validationA.純化水、培養(yǎng)基。Purified water, Culture MediaB.試劑、試液、對(duì)照品等。Reagents, solutions and reference standardsC.儀器、器具等。Instruments, utensilsD.其它條件。Etc.6.1.3清潔SOP名稱及編號(hào)/SOPs name and number regarding to cleaning清潔SOP名稱SOPs name regarding to cleaning SOP編號(hào)SOPs No.6.1.4清潔介質(zhì)、用品及設(shè)備/Media, articles and equipments for cleaningA.清潔介質(zhì)：飲用水、純化水、壓縮空氣、75乙醇。 Cleaning media: drinking water, purified water, compressed air and 75% ethanolB.清潔用品：清潔布；一次性清潔布。 Articles for cleaning: cleaning cloth, single-service cleaning clothC.清潔設(shè)備：UC-3000P型超聲波清洗機(jī)、全自動(dòng)洗衣機(jī)。 Equipments for cleaning: UC-3000P-ultrasonic washing unit, automatic washer6.1.5清潔原則/Cleaning principle各工序嚴(yán)格按照自己工序使用的設(shè)備標(biāo)準(zhǔn)操作規(guī)程，在完成XXXX片10mg規(guī)格生產(chǎn)后，對(duì)本工序使用的設(shè)備及容器具進(jìn)行清潔，清潔結(jié)束后通知QC人員取樣檢測(cè)，要求微生物及化學(xué)檢測(cè)結(jié)果均符合規(guī)定的殘留限度要求。Production staff should strictly follow the operating SOP for individual process and clean equipments and utensils used in the manufacturing after 10mg strength XXXX Tablets are finished, then inform QC analyst to sample. The object of clean is to make sure chemical residual and microbial residual meet pre-determined criteria. 6.1.6設(shè)備表面積/Surface area of individual equipments設(shè)備名稱Equipment Name表面積（m2）Surface area合計(jì) Total注：計(jì)算允許殘留限度時(shí)，總面積按照2904dm2計(jì)算。Notes: Permitted residual level is calculated based on 2904dm2 of total surface area.6.1.7取樣位置匯總表/Sampling locations取樣點(diǎn)編號(hào)Sampling No.取樣位置（材質(zhì)）Sampling locations(construction materials)T001T002T003T004T005T006T007T008T009T010T011T012T013T014T015T016T017T018T019T020T021T022T023T024T025T026T027T028T029T030T031T032T033T034T035T036T037T038T039T040T041T042T043T044T045T046T047T048T049注：取樣點(diǎn)示意圖見(jiàn)附件二Note: Schematic diagram is shown as attachment 2 6.2XXXX殘留限度標(biāo)準(zhǔn)的設(shè)定/Criteria of residual limitXXXX的最大殘留限度應(yīng)設(shè)定為25g/dm2。Maximum permitted residual limit of XXXX is 25g/dm2微生物殘留不得超過(guò)20cfu/25cm2。Microbial residual must not exceed 20cfu/25cm26.3取樣程序及取樣方法/Sampling procedure and method6.3.1取樣程序：生產(chǎn)人員清潔結(jié)束后，通知QC人員取樣。取樣應(yīng)在清潔完成2小時(shí)內(nèi)取樣。取樣時(shí)，取樣人員首先對(duì)生產(chǎn)設(shè)備進(jìn)行目檢，可接受標(biāo)準(zhǔn)為：目視無(wú)可見(jiàn)殘留。目檢合格方可取樣。取樣時(shí)先進(jìn)行微生物取樣，再進(jìn)行化測(cè)取樣。 Sampling procedure: QC staff will be informed to sample after production staff finish cleaning. Sampling should be performed within 2 hours once cleaning is finished. When sampling, these equipments should be visual inspected the firstly, the acceptable criteria: No visual residual. Sampling will not be conducted if visual inspection doesnt meet the requirement. Microbiological sample should be sampled fisrtly, and then chemistry sample can be sampled secondly.6.3.2取樣方法/Sampling methodA.用于藥物活性成分殘留測(cè)定樣品的取樣/Sampling for API residuall 選擇適宜的PVC取樣模板/Choose a suitable PVC sampling template若取樣點(diǎn)表面形狀規(guī)則，選擇面積為100cm2的PVC模板；If the surface of sampling location is regular, choose a 100cm2 of PVC template.若取樣點(diǎn)表面形狀不規(guī)則,使用不同規(guī)格PVC模板,必須保證被取樣面積為100cm2。If the surface of sampling location is irregular and PVC sampling template can be used with different shapes, then sampling area must be not less than 100cm2.l 取一燒杯，倒入適量色譜甲醇，將取樣用棉簽用色譜甲醇浸濕，在杯壁上擠掉棉簽上多余的溶劑；將棉簽頭按在取樣點(diǎn)表面上，用力使棉簽桿稍彎曲，以使棉簽一面與取樣點(diǎn)表面完全接觸，平穩(wěn)而緩慢地按圖一所示方向各均勻擦拭一遍，然后，翻轉(zhuǎn)棉簽，用另一面按圖二所示方向進(jìn)行第二次擦拭。擦拭完畢，將棉簽頭置具塞試管中。對(duì)每個(gè)取樣點(diǎn)，用兩根棉簽重復(fù)取樣兩次，并將兩個(gè)棉簽頭置同一具塞試管中。擦拭過(guò)程應(yīng)覆蓋整個(gè)PVC模板內(nèi)所有表面。取樣完畢，用一次性清潔布沾75%的乙醇擦拭被取樣點(diǎn)表面。Add appropriate amount of methanol into a beaker, presoak a swab used for sampling with methanol. Expel the excess methanol from swab by pressing it against the beaker wall. Put the top of swab on the surface of sampling location, bend the handle of swab slightly to make a face of the swab completely contact the surface of sampling location, then swab this sampling location as the direction shown in schematic diagram 1.Turn this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. Then put the top of swab into a scintillation vial with stopper. There will be two swabs used to clean each sampling location, total two swabs will be collected into one scintillation vial. The whole face within the PVC template should be covered during swabbing. After sampling, clean the surface of sampling location with single-service cleaning cloth soaked with 75% ethanol.圖一 圖二Schematic diagram 1 Schematic diagram 1B.微生物檢測(cè)樣品取樣/Sampling for microbial testingl 接觸法/Contact plate若取樣點(diǎn)位置光滑平整，面積大于25cm2，使用表面積為25cm2的接觸碟以接觸法取樣，取樣方法為：在靠近取樣點(diǎn)的位置打開(kāi)接觸碟上蓋，輕壓接觸碟使其與取樣表面完全接觸后，移開(kāi)接觸碟，立即蓋上平皿并作好標(biāo)識(shí)。取樣完畢，用一次性清潔布蘸75的乙醇擦拭被取樣點(diǎn)表面。If the surface of sampling location is smooth and area is more than 25cm2m 25cm2 of contact plate can be used for sampling. Sampling method is shown as following: open the cap of contact plate near sampling location, slightly press plate to make it completely contact the surface of sampling location, then remove the plate, immediately cap and label it. After sampling, clean the surface of sampling location with a single-service cleaning cloth soaked with 75% ethanol.l 擦拭法/Swabbing method若取樣點(diǎn)位置凸凹不平或面積小于25cm2，可選擇適宜大小的PVC模板確定取樣面積。取一支3M快速取樣棉簽，將其紅色按閥彎折45角，至聽(tīng)到按閥折斷。擠壓球腹使肉湯流入試管底端。抽出棉簽，將棉簽頭按在取樣表面上，使棉簽與取樣表面成30角，并用力使其稍彎曲，平穩(wěn)而緩慢地按圖一所示方向均勻擦拭一遍，然后，翻轉(zhuǎn)棉簽，用另一面按圖二所示方向進(jìn)行第二次擦拭。擦拭過(guò)程應(yīng)覆蓋整個(gè)PVC模板內(nèi)所有表面。擦拭完畢，將棉簽置試管中插緊并作好標(biāo)識(shí)，取樣完畢，用一次性清潔布蘸75的乙醇擦拭被取樣點(diǎn)表面。If the surface of sampling location is not smooth or the area is less than 25cm2, choose an appropriate PVC template to determine sampling area. Take a 3M rapid sampling swab, bend the red valve to 45angle until valve is fracted. Expel the abdomen of ball to make broth flow into the bottom of tube, then draw out swab and press the top of swab on the surface of sampling location to make the angle between swab and sampling surface be 30and bend emphatically it, swab this sampling location as the direction shown in schematic diagram 1.Turn this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. The whole face within the PVC template should be covered during swabbing. After sampling, put swab in tube, seal and label, then clean the surface of sampling location with single-service cleaning cloth soaked with 75% ethanol.6.3.3化學(xué)檢測(cè)方法及可接受標(biāo)準(zhǔn) Chemical analytical method and acceptable criteriaA. 標(biāo)準(zhǔn)品溶液的配制： Standard solution: 標(biāo)準(zhǔn)品溶液濃度計(jì)算公式：Calculation formula of concentration for standard solutionB. 供試品的配制： Test solution: C.色譜條件: Chromatographic conditionsD.系統(tǒng)適用性試驗(yàn)/System suitability testE.計(jì)算/Calculationl 按外標(biāo)法計(jì)算設(shè)備表面殘留量。Calculate the residual on the surface of equipment according external reference methodF.可接受標(biāo)準(zhǔn)/Acceptable Criteria所有取樣點(diǎn)藥物活性成分殘留量均不得超過(guò)25g/100cm2。對(duì)于計(jì)算修約后的為0g/100cm2的檢測(cè)結(jié)果，報(bào)告為1g/100cm2；對(duì)于未檢測(cè)出的檢測(cè)結(jié)果，報(bào)告為ND。Residual of API on all sampling locations must not exceed 25g/100cm2. If testing results is 0g/100cm2 after rounded off, report it as 1g/100cm2; if testing results are “not detectable” , report it as ND.6.3.4微生物檢測(cè)方法及可接受標(biāo)準(zhǔn) Microbial analytical method and acceptable criteriaA. 培養(yǎng)/Incubationl 以cfu/25cm2形式報(bào)告Report the result in cfu/25cm2l 直接以培養(yǎng)結(jié)束后的菌落數(shù)報(bào)告。無(wú)菌落生長(zhǎng)以1 cfu/25cm2報(bào)告。Report the number of cfu after incubation is finished, if there is no growth of microorganism, report is as 1 cfu/25cm2.l 可接受標(biāo)準(zhǔn)：所有取樣點(diǎn)微生物殘留不得超過(guò)20cfu/25cm2。Acceptable criteria: microbial residual on all smapling locations must be NMT 20cfu/25cm2.6.4清潔驗(yàn)證過(guò)程/The process of cleaning validation6.4.1XXXX片10mg規(guī)格生產(chǎn)結(jié)束后，制造部按各設(shè)備相應(yīng)SOP的規(guī)定，對(duì)生產(chǎn)設(shè)備及容器具進(jìn)行清潔。 Production staff will cle