GLP(良好實驗室規(guī)范)課件

1、GLP(良好實驗室規(guī)范)國家為了保證藥品的質量安全制定的一系列規(guī)范，包括：GAP中藥材生產質量管理規(guī)范 GMP藥品生產質量管理規(guī)范 GLP藥物非臨床研究質量管理規(guī)范 GCP藥物臨床試驗管理規(guī)范 （Good Clinical Practice） GSP藥品經營質量管理規(guī)范GUP藥品使用質量管理規(guī)范這些嚴格的規(guī)范被逐漸應用到其它相關領域，尤其是食品行業(yè)：GAP（Good Agricultural Practice ）:良好農業(yè)規(guī)范GMP（Good Manufacturing Practices） :良好操作規(guī)范GLP （Good Laboratory Practice ）:良好實驗室規(guī)范GSP（G

2、ood Supplying Practice ）：良好經營（供應）規(guī)范1h第1頁，共55頁。GLP(良好實驗室規(guī)范) GLP是英文Good Laboratory Practice 的縮寫，中文直譯為良好實驗室規(guī)范。 GLP是就實驗室實驗研究從計劃、實驗、監(jiān)督、記錄到實驗報告等一系列管理而制定的法規(guī)性文件，涉及到實驗室工作的所有方面。它主要是針對醫(yī)藥、農藥、食品、食品添加劑、化妝品、獸藥等進行的安全性評價實驗而制定的規(guī)范。 制定GLP的主要目的是嚴格控制化學品安全性評價試驗的各個環(huán)節(jié)，即嚴格控制可能影響實驗結果準確性的各種主客觀因素，降低試驗誤差，確保實驗結果的真實性。2h第2頁，共55頁。GL

3、P(良好實驗室規(guī)范) GLP始于20世紀70年代。新西蘭是第一個建立實驗室登記法的國家。 1976年美國食品藥品管理局（FDA）制定了僅限于藥品的GLP規(guī)范草案。 1980年由美國聯(lián)邦環(huán)保局（EPA）在聯(lián)邦殺蟲、殺菌、殺鼠劑法中發(fā)布了有關農藥的GLP標準。加拿大、日本、韓國等國家先后發(fā)布了本國的GLP法規(guī)。 歐共體在1975年5月公布了關于藥品藥理毒理、臨床及臨床標準草案法規(guī)，在1986年提出GLP草案，1988年又發(fā)布GLP檢查法令。歐共體GLP與經濟合作與發(fā)展組織（OECD）的GLP原則一致。 1993年12月我國原國家藥品監(jiān)督管理局頒布了“藥品非臨床研究質量管理規(guī)定”(試行)。國家環(huán)境保

4、護總局等部委也先后制定了本行業(yè)的GLP標準。我國農藥行業(yè)GLP工作始于2002年。 3h第3頁，共55頁。GLP(良好實驗室規(guī)范)CONTENTS 內容1、整潔有序的實驗室日常管理 GOOD HOUSEKEEPING PRACTICE2、安全規(guī)范 SAFETY PRACTICE3、符合專業(yè)要求的操作 GOOD OPERATIONAL PRACTICE4、純凈水 PURIFIED WATER5、標準物質 REFERENCE MATERIALS6、標準溶液 STANDARD SOLUTIONS7、留樣 RETAINED SAMPLES8、實驗室器皿的清潔 CLEANING OF LABORATOR

5、Y WARE9、化學通風櫥 FUME CUPBOARDS10、層流通風柜（超凈工作臺） LAMINAR FLOW HOODS11、實驗室能力驗證 LABORATORY PROFICIENCY TEST4h第4頁，共55頁。現(xiàn)場的5S！GLP(良好實驗室規(guī)范)1、GOOD HOUSEKEEIPNG PRACTICE整潔有序的實驗室日常管理Work flow: A well organized laboratory should minimize the amount of backtracking and retracing of steps.工作流程：實驗室的布置應合理有序，以有助于提高工作效

6、率。Labs shall be kept clean and tidy and free from unnecessary clutter and equipment.實驗室應保持清潔，整齊，不放置不需要的物品和儀器。All gangways, aisles and exits will be free to allow easy access.通道，走廊和出口保持通暢。All equipment, glassware and other supporting instrumentation will be back in their proper place after use.所有儀器，玻

7、璃器皿和輔助器具使用后應放加原處。A label will be placed on each cupboard and draw to identify its contents.櫥柜和抽屜應有標識。Most chemicals in the laboratory are potentially hazardous,they shall be properly labeled and separately stored.化學品應分類存放，并按性質作危害性標識。5h第5頁，共55頁?，F(xiàn)場的EHS！GLP(良好實驗室規(guī)范)2、SAFETY PRACTICE-1 安全規(guī)范Personnel wil

8、l wear durable clothing that covers the arms, legs, torso and feet. Open-tode shoes and sandals will not be worn. 實驗室人員應穿著牢固的能遮蓋手臂、腿、身體和腳的服裝，不得穿著露趾鞋和拖鞋。A clean, fastened cotton laboratory coat will be worn. Laboratory coats will not be worn in refreshment areas or lunch rooms.應穿著緊身的棉質工作服，工作服不可穿進茶點休息

9、區(qū)域或食堂。Eye protection will be worn unless the analyst can demonstrate that adequate protection is provided by other means.實驗室應配備保護眼睛的設施，否則應配戴護眼鏡。Each laboratory has dedicated hand washing facilities-including soap and paper towels. Hands are washed on entering the laboratory before starting analysis,

10、 and when entering and exiting the laboratory for lunch or going to the toilet.實驗室應配備專用洗手設施-包括清潔劑和紙巾。進入實驗室開始分析前，離開實驗室進餐廳和由餐廳回實驗室，或去洗手間均須洗手。6h第6頁，共55頁。現(xiàn)場的EHS！GLP(良好實驗室規(guī)范)2、SAFETY PRACTICE-2 安全規(guī)范Appropriate gloves are worn when handling substances that may be absorbed through the skin or that are corr

11、osive, harmful or may irritate the analyst.處理易被皮膚吸收或腐蝕有害或刺激性的物質時應帶適當?shù)氖痔住haracters of chemicals, such as “Flammable”, “Corrosive” etc. shall be correctly identified and labeled.化學品的特性，如“易燃”，“腐蝕”等應正確標識。Cylinders shall be fixed and clearly labeled.鋼瓶應清楚標識，并固定。Cuts and grazes to the skin are adequately

12、 covered by suitable dressings.傷口和皮膚擦破處應適當?shù)匕蠊?。Personnel will not work in a laboratory alone.不可單獨在實驗室工作。Eating, drinking and smoking are prohibited in the laboratory at all times.任何時候均不得在實驗室吃、喝和抽煙。7h第7頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-1符合專業(yè)要求的操作-試劑的使用與配制-1Solvent bottles are always cov

13、ered as they will readily absorb moisture and contaminants from the air.溶劑易吸收空氣中的水分和污染物，溶劑瓶必須隨時蓋緊。A pipette will not be used to pipette directly from the bottle unless it is an automatic pipette. The remaining solvent is not returned to the stock bottle. It must be treated as waste.不可用移液管直接從瓶中移取溶劑或溶

14、液，應傾倒入容器內移取，剩余溶劑不可倒回貯液瓶，應作廢棄物處理。A spatula or spoon will not be placed directly into the bottle for solids. The required quantity is decanted into another container from which the material will be retrieved. The remaining material will not be returned to stock bottle. It should be treated as waste.不可

15、用刮勺或匙直接從瓶中取用固體試劑，應在另一容器中傾入所需量。剩余試劑不可倒回原容器，應作廢棄物處理。8h第8頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-2符合專業(yè)要求的操作-試劑的使用與配制-2Laboratory personnel shall be made aware of their responsibilities in the use of suitable reagents, solvents, culture media, reference materials and laboratory ware in terms of t

16、he types of analysis they conduct.實驗室人員應明確其有責任根據(jù)所進行的測試使用適合的試劑、溶劑、培養(yǎng)基、參照物和實驗室器皿。Any possible contamination, including Leftovers that has been returned to the containers.任何可能導致污染的操作，包括將取出未用完的試劑、溶劑、培養(yǎng)基、參照物放回容器，受影響的物質均應視為失效。INTEGRITY OF REAGENTSAll reagent containers shall be labeled and tightly closed.

17、 They shall bear the original label.所有試劑容器均應標識和蓋緊。容器上的標貼必須為原標貼。INTEGRITY OF REAGENTS9h第9頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-3符合專業(yè)要求的操作-試劑的使用與配制-3The person responsible for the preparation of the reagent shall be identifiable either from the label or from records.試劑的配制人應在標貼上標識或在記錄中寫明。Labor

18、atory shall establish written procedures for preparation of reagent solutions and culture media. Records of such preparation shall be maintained.實驗室應建立試劑溶液和培養(yǎng)基配制方法的文件。應保存配制記錄。Records for reagent solutions shall include measured weights and volume, burette readings, pH readings, calculation of standa

19、rdization factor and solution concentration.試劑溶液配制記錄應包括重量，體積，滴定管讀數(shù)，PH讀數(shù)標定因子的計算和溶液濃度。10h第10頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-4符合專業(yè)要求的操作-試劑的使用與配制-4The preparation record for culture media shall include medium name, batch number, amount prepared, pH before and after autoclaving autoclave t

20、ime and pressure.培養(yǎng)基的配制記錄應包括名稱、批號、配制量、壓熱鍋處理前后的PH值，處理時間和壓力。Where laboratory prepares its own media, the chemicals used for such preparation shall be verified to be of the appropriate quality before use.如實驗室自己制備培養(yǎng)基，使用前應確認所用化學品符合質量要求。“hazardous substance” shall be kept separately from other reagents an

21、d held in locked cabinets.危險物質應與其它試劑分別存放，并加鎖。11h第11頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-5符合專業(yè)要求的操作-試劑的使用與配制-5Preparation And Storage Of Culture media培養(yǎng)基的制備和存儲Culture media must be prepared and stored at the specified temperature and under the specified conditions according to the manufactu

22、rers instructions or method requirements. Each lot of prepared or purchased culture media must verified for its effectiveness.培養(yǎng)基必須按照制造商的說明或方法要求在規(guī)定的溫度和條件下制備和存放。無論是購買的或制備的培養(yǎng)基，其有效性必須驗證。Prepared Plates of Culture Media: Poured plates of agar Media are especially vulnerable to infection, dehydration and

23、 chemical degradation. Aseptic preparation and storage are essential to protect plates from microbial infection.培養(yǎng)基制備平板，例如瓊脂傾注平板，特別易受微生物侵染，脫水，和化學降解，為使平板不受微生物侵染，必須進行無菌制備和存放。12h第12頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-6符合專業(yè)要求的操作-試劑的使用與配制-6GR (Guaranteed reagents) 保證試劑 （優(yōu)級純）（一級） 綠色AR (Analytic

24、al reagents) 分析純 （二級） 紅色CP (Chemical pure) 化學純 （三級） 藍色LR (Laboratory reagents) 實驗試劑 （四級） 中黃色Correctly Select Reagents 正確選用試劑GR: 用于精密度和準確度較高的分析AR: 用于常規(guī)分析工作CP: 通常不用于分析工作，尤其不適合配制標準溶液LP: 不適合用于分析工作此外，有特定用途的試劑純度有高純試劑，如光譜純、色譜純等。AR can be used for preparing standard solutions but not for standardization.分析純

25、試劑可用于配制標準溶液，但不可用于標定。13h第13頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-7符合專業(yè)要求的操作-稱量過程-1Glass vessels used to weigh material will not be wiped with a dry cloth as this causes static electricity build up in the container. Do not put material to be weighed in the weighing dish more than 2/3 of its v

26、olume.用于稱量樣品或試劑的玻璃器皿不可用干織物擦試以免產生靜電。樣品不能超過稱量皿體積的2/3。All samples and containers are at the same temperature as the weighing device. Therefore, all materials are allowed to equilibrate to room temperature prior to use.所有樣品和容器應與稱量裝置置于同一溫度，以使所有物料使用前在室溫下平衡。All weighing devices are calibrated or verified p

27、rior to use. Verification shall be conducted at and 2 times of target value.稱量儀器使用前應校驗或驗證，驗證應在1/2及2 倍目標稱量值處進行。14h第14頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-8符合專業(yè)要求的操作-稱量過程-2Bare hand can never touch the weights, clean gloves should be worn.不可用手接觸砝碼，應佩戴干凈手套。Oven should be equilibrated at speci

28、fied temperature prior to testing the loss of weight on drying. Sample after drying shall be cooled for a fixed and constant time interval.進行干燥失重測試前，應先將烘箱開啟在規(guī)定溫度下達到平衡。干燥后樣品的冷卻時間應恒定。Properly place objects being dried in the desiccator, no stacking is allowed.在干燥器中的物體不可疊放。15h第15頁，共55頁。GLP(良好實驗室規(guī)范)3、GO

29、OD OPERATIONAL PRACTICE-9符合專業(yè)要求的操作-容量器具的使用-1The use of drying solvents (e.g. acetone), compressed air and paper towels will be avoided, where possible, as these may be other sources of damage or contamination.盡可能避免使用干燥溶劑（如丙酮），壓縮空氣和紙巾以免可能的損壞或污染。Glass stoppers purchased with the volumetric flasks will

30、 remain with that flask.容量瓶的玻璃塞須保持原配。Use of pipettes: the solutions are not mouth pipetted irrespective of their nature.任何溶液均不可用移液管通過嘴吸取。All pipettes are inspected carefully prior to use. It will be checked for cracks in the tip; if present it will be discarded. Pipettes are clean and dry prior to u

31、se.移液管在使用前應檢查頂端是否有裂紋；移液管使用前必須清潔干燥。16h第16頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-10符合專業(yè)要求的操作-容量器具的使用-2The pipette is rinsed at least twice with the sample solution before use.移液管使用前應至少用樣品溶液潤洗兩次。When removing solution from a flask, sufficient volume is drawn to slightly above the mark, the solu

32、tion is allowed to draw down to the mark by touching the tip of the pipette to the flask surface. Any excess fluid from the pipette is wiped in a downward motion then the aliquot is delivered.當由容量瓶移出溶液時，溶液體積應略高于刻度，然后用移液管尖端接觸溶量瓶表面的方法將溶液調節(jié)至刻度。Note: most pipettes are designed not to be expelled (i.e. l

33、iquid should remain in the tip after use).多數(shù)移液管都無須將殘留液趕了（即將殘留液留在移液管尖端）。Volumetric glassware can not be kept in heating environment, or in refrigerator or cooling cabinet. Do not hold the quantitative part of the volumetric glassware with hand.所有容量器具不能存放在加熱環(huán)境下或冰箱內。使用時不能用手捂住容量部分。 17h第17頁，共55頁。GLP(良好實驗

34、室規(guī)范)3、GOOD OPERATIONAL PRACTICE-11符合專業(yè)要求的操作-容量器具的使用-3Graduated measuring cylinders are read by placing them on an even bench, and observing the meniscus at eye level. Volume is equivalent to the bottom of the meniscus.刻度量筒放置于平坦的桌面上讀數(shù)，視線應與彎月面同一水平，由彎月面底部讀取體積。Items such as beakers, Erlenmeyer flasks an

35、d other glassware with rudimentary volume markings will not be used for measuring volume.帶有粗刻度的器皿，如燒杯、三角瓶等玻璃器皿不可用于量度體積。All volumetric glassware shall be verified before use; Pipettes shall be verified once every 3 month, and auto pipettes verified daily before use, record quarterly; Whether volumetr

36、ic flask is verified quarterly shall be based on uncertainty contribution. All verification is recorded.所有容量器具使用前必須經過驗證。移液管每三個月驗證一次，移液槍每次使用前驗證，并每三個月記錄一次。容量瓶的驗證根據(jù)它對方法結果的不確定度貢獻在方法的SOP中注明是否需要每三個月驗證一次。所有驗證均須記錄。18h第18頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-12符合專業(yè)要求的操作-容量器具的使用-4All measurable glass

37、ware, such as pipette and volumetric flask, should be verified with certified thermometer, weights should also be certified and in calibration status.容量器皿（如移液管和容量瓶）的驗證應使用處理校驗狀態(tài)的有證溫度計及砝碼.Volumetric measurement is an essential element in an analytical laboratory as many types of determination require

38、specific dilutions and quantitative delivery of solutions.容量分析是分析實驗室的基本內容，因為許多測試均涉及定量稀釋和溶液的定量轉移。Regardless of type of volumetric glassware, where accuracy is required, especially for quantitative analysis, all of such volumetric equipment shall be calibrated.容量儀器應恰當?shù)鼐S護和檢查，任何容量分析玻璃器皿,只要有精確度的要求，尤其是定量分

39、析，所有這些儀器均應進行校驗。19h第19頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-13符合專業(yè)要求的操作-容量器具的使用-5Coca-cola requires that “class A” glassware shall be used for volumetric analysis. Does this mean no calibration is necessary for any glassware marked “A”?可口可樂系統(tǒng)規(guī)定使用”A“級容量器皿，這是否意味著凡是標識”A“的容量器皿都不必要校驗？甚至使用了十余年也無需驗

40、證其是否仍符合A級要求嗎？Is your Class A glassware supplied with a serialized certificate of precision?你的”A“級容量器皿有不重復編號的效證書嗎？Glass A glassware need only be used where such volumetric accuracy is critical to the performance of the method and, where it is required, the glassware must be calibrated as conforming t

41、o Class A tolerance.A級玻璃器皿僅在容量準確性對方法結果而言為必須時才使用，當需要用A級時，必須校驗以確認符合A級的容許誤差。20h第20頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-14符合專業(yè)要求的操作-容量器具的使用-6Glassware used for measuring samples, standards and reagents for analytical procedures must be Class A.用于測量進行測試的樣品、標準和試劑的玻璃器皿必須是A級。All plastic volumetric

42、 containers are Class B.所有塑料容量分析容器均是B級。Syringes and automatic tip pipettors are not listed as Class A.注射器和自動移液管不列為A級。21h第21頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-15符合專業(yè)要求的操作-樣品處理Sample preparation: All preparations will be done to mininize the potential risk of contamination or degrading the

43、 material to be analyzed.樣品制備應將待測物質潛在的污染和降解或變質可能性降至最小。22h第22頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-16符合專業(yè)要求的操作-記錄保存Recording Professionally.記錄保存應符合規(guī)范。Log book is usually not original record. Adequate information and raw data, such as calculation, shall be maintained.數(shù)據(jù)表通常并非原始記錄，記錄應包含充分的信息及原始

44、數(shù)據(jù)，例如計算。Record shall be made at the time when the activity is carried out, never do it afterwards.確保記錄的實時性。避免任何形式的”補記“。23h第23頁，共55頁。GLP(良好實驗室規(guī)范)3、GOOD OPERATIONAL PRACTICE-17符合專業(yè)要求的操作-培訓A number of extraneous conditions may influence the precision of a given measurement. They include temperature, me

45、thod of delivery, depth of color of the solution, type of meniscus, calibration to contain or deliver a definite volume, and so forth. Thus proper training of personnel and continuing observation of their operations shall be instituted as part of the quality assurance process to minimize or eliminat

46、e problems associated with these extrinsic factors which can affect precise liquid measurements.許多外部條件將影響測試的精確性，例如溫度，樣品或溶液的轉移方法，溶液顏色深度，液柱彎月面的形狀，確定體積的容量或轉移量的校驗等。因此，恰當?shù)娜藛T培訓，操作的持續(xù)監(jiān)視應成為實驗室品質保證過程的一部分，以減少或消除這些影響液體精確測量的外部因素。24h第24頁，共55頁。GLP(良好實驗室規(guī)范)4、PURIFIED WATER-1 純凈水Purified water is one of the most cr

47、itical but most often neglected reagents used in laboratory operations. Use of improperly purified water may account for the failure of analysis.水是最重要而常被忽視的試劑之一，使用不合格的水可能會導致分析的失敗。Distillation of water will not always ensure quality. The materials and construction of the distiller, and the character

48、of raw water all influence the quality of the distillate. The storage container, too, can significantly influence the purity of the water.蒸餾并不總能確保水的質量，蒸餾裝置的材質和構造，以及原水的品質均影響蒸餾水的質量。儲存容器也將顯著地影響蒸餾水的質量。25h第25頁，共55頁。GLP(良好實驗室規(guī)范)4、PURIFIED WATER-2 純凈水Stills need periodic cleaning to remove scale.蒸餾裝置需定期清潔和

49、除垢。For more precise analysis, it may be necessary to use water distilled from quartz or all-borosilicate glass distillation system.要求較嚴格的分析可能需使用石英硼硅玻璃蒸餾裝置精餾的水。Purified water can be defined as water that has been distilled and/or deionized so that it meets relevant standard or specifications.純凈水為經蒸餾和

50、/或去離子的水，以達到或高于相關的標準或規(guī)格。26h第26頁，共55頁。GLP(良好實驗室規(guī)范)4、PURIFIED WATER-3 純凈水分析實驗室用水國家標準一、二、三級實驗室用水的技術指標（GB6682-92)名稱一級二級三級PH值范圍（25）-5.0-7.5電導率（25），S/cm. 0.115可氧化物質（以O2計），mg/L -0.080.4吸光度（254nm,1cm光程） 0.0010.01-蒸發(fā)殘渣（105 2），mg/L -1.02.0可溶性硅（以SiO2計），mg/L 0.010.02-一級水用于有嚴格要求的分析實驗，如液相色譜分析用水等。二級水用于無機痕量分析，如原子吸收光

51、譜分析用水等。三級水用于一般的分析工作。27h第27頁，共55頁。GLP(良好實驗室規(guī)范)4、PURIFIED WATER- 4 純凈水Grade 1 water should be produced by further treatment of grade 2 water, for example by reverse osmosis or ion exchange followed by filtration through a membrane filter of pore size 0.2m to remove particle matter or re-distillation f

52、rom a fused silica apparatus.一級水可用二級水經過石英設備蒸餾，或離子交換或反相滲透再經0.2m孔徑的薄膜過濾器處理獲得。Grade 2 water can be produced by multiple distillation. Re-distillation can also use sub-boiling silica distillation apparatus.二級水可用多次蒸餾或離子交換等制得，二次蒸餾水一般可達到二級標準。第二次蒸餾也可采用石英亞沸蒸餾器。Grade 3 water can be produced by single distilla

53、tion, by ion exchange, or by reverse osmosis. Unless otherwise specified, it should be used for ordinary analytical work.三級水可用一次蒸餾，離子交換，或反相滲透制得。通常，三級水可用于普通的分析工作。28h第28頁，共55頁。GLP(良好實驗室規(guī)范)5、REFERENCE MATERIALS- 1 標準物質Definitions(定義)：Reference Material (RM): A material or substance, one or more propert

54、ies of which are sufficiently well established to be used for the calibration of apparatus, the assessment of a measurement method, or for assigning values to materials.參照物（RM）：一種材料或物質，其一項或多項物性值得到充分確定，用于校驗儀器和評價測量方法或確定材料的性能值。Certified Reference Material (CRM):A reference material, one or more of whos

55、e property values are certified by a technically valid procedure accompanied by or traceable to a certificate or other documentation which is issued by a certifying body.有證參照物（CRM)：一種材料或物質，其一項或多項特性值通過采用技術上獲得認可的方法并可溯源至認可機構頒發(fā)的證書或其它的文件而獲得認證。29h第29頁，共55頁。GLP(良好實驗室規(guī)范)5、REFERENCE MATERIALS- 2 標準物質Certifie

56、d Reference materials 有證基準物A certified reference material can be defined as a homogeneous material with specific properties such as identity, purity, and potency that has been measured and certified by a qualified and recognized organization.有證基準物是經有資質并獲得承認的機構測定和鑒證的具有特定性質，例如屬性、純度、強度的均勻物質。注：中國國家標準將有證

57、標準物質為一級和二級These materials are quite expensive and may or may not be used in everyday operations. They are often used to “calibrate” and/or assay so-called “working or secondary reference materials.日常操作可使用經有證基準物標定的”二次標準“。30h第30頁，共55頁。GLP(良好實驗室規(guī)范)5、REFERENCE MATERIALS- 3 標準物質Care must be taken for the

58、 certified reference materials to ensure that they are packaged, stored and handled properly to prevent deterioration. Certificate and records of receipt and use shall be maintained.有證基準物必須妥善包裝、存放和處置，以防止變質，應保存收貨和使用記錄及證書，計算時應按證書標明的含量。The laboratory shall assign suitable staff as monitor(s) for certif

59、ied reference materials. Their duties shall include ordering or assisting in the ordering of new reference materials, checking calculations of assays, refilling empty working supply containers, keeping lists of laboratory-available certified reference materials up to date.指定合適人員監(jiān)控有證基準物，其職責包括訂購或協(xié)助訂購的

60、基準物，檢查計算，向專用的空容器中補充基準物溶液，和更新實驗室有證基準物清單。31h第31頁，共55頁。GLP(良好實驗室規(guī)范)5、REFERENCE MATERIALS- 4 標準物質It is preferable to keep sign-in and sign-out log books. Each analyst using a certified reference material shall register the name of the reference material, the date and time it is taken and returned, and h