CGMP文件 化学药品和溶剂的接收,保管和处理的标准操作程序SOP

1、标准操作程序Standard Operating Procedure文件编码Doc. No.: 颁发日期：Issue Date: 生效日期：Effective Date: 替代： Supersedes: 复审日期：Review Date: 页码：第1页共8页Page No.: 1 of 8标题：化学药品和溶剂的接收，保管和处理标准操作程序TITLE: RECEIPT, MAINTENANCE AND HANDLING OF CHEMICALS AND SOLVENT1.0 目的 Purpose:制定QC用于分析的化学药品和溶剂的接收，保管和处理程序。Lay down a procedure f

2、or receipt, handling and maintenance of chemicals and solvents used for analysis in Quality Control department.2.0 范围 Scope:本程序适用于QC化学药品和溶剂的接收，保管和处理，同时也适用于实验室工作的安全。This procedure is applicable for receipt, maintenance and handling of all chemicals and solvents used in Quality Control department, and

3、 also applies to the safety in laboratory during working.3.0 定义 Definitions: 无 Nil4.0 责任 Responsibility:所有QC人员有责任按照本程序的规定操作。All Quality Control personnel are responsible for performing the activity as per the procedure.5.0 程序 Procedure：5.1 通则 General Instructions:5.1.1所有的化学药品只能从经授权的生产商和经销商那获得。All ch

4、emicals should be procured only from authorized manufacturer and dealer.5.1.2在需要的时候，要使用合适的安全防护用具，比如：面具，手套，安全护目镜，安全鞋。Use appropriate safety appliances like mask, hand gloves, safety goggles and safety shoes wherever necessary.5.1.3在处理易燃性的溶剂时，要确保旁边有灭火器。While handling flammable solvents, ensure the fir

5、e extinguisher is nearby.5.1.4所有的加热活动须在通风橱内进行。All heating activities should be carried out in fumehood.5.1.5要仔细，小心地处理强酸和有毒物质。Strong acids, poisonous material should be handled with care and caution.5.1.6避免化学药品和溶剂和皮肤、眼睛直接接触。Avoid chemicals and solvents from coming in contact with skin and eyes. 5.1.7

6、 要用大量的冷水来冲洗溅在皮肤上的药品。Rinse splashes of the sample on the skin with plenty of cold water.5.1.8 如果腐蚀的物质伤到眼睛了，立刻用缓流的水冲洗眼睛， 眼皮要睁大，不断转动眼睛，然后马上找眼科医生。If corrosive substances affect the eyes, rinse the eyes with a gentle jet of water. Hold the eyelids wide open, and move the eyes in all directions. Consult t

7、he eye specialist immediately.5.1.9 不要把不兼容的化学药品放得太近。Do not keep non-compatible chemicals close to each other.5.1.10 所有的化学药品和溶剂都得按标签上的条件储存。All chemicals and solvents should be stored as per the condition mentioned on label.5.1.11使用完后，把化学药品和溶剂放在指定的地方。After use, keep the chemicals and solvents at its i

8、ntended place.5.1.12在处理危险化学药品前，要先仔细阅读有关潜在危险的详细信息。Before handling hazardous chemicals, first read carefully all the detail information regarding potential hazards.5.1.13确保灭火器的有效期，而且易取得使用。Ensure the validity of fire extinguisher and that they are easily accessible.5.1.14放置有药品和有毒物质的解毒剂的救护箱应放在容易拿到的地方。Fi

9、rst-aid box with all necessary medicines and antidotes for poisonous material should be kept at easily accessible place.5.1.15防止烟和蒸发物的吸入。Avoid inhalation of fumes or vapors.5.1.16装溶剂和液体化学药品的所有玻璃器皿都应贴好标签。All glassware containing solvents or liquid chemicals should be properly labeled.5.1.17当离开实验室的时候，

10、关掉那些没有使用的仪器的电源。While leaving the laboratory, ensure that the power supply of all the instruments which are not in use are switched OFF.5.1.18对在化学检测实验室里工作的人进行急救培训和消防培训。First-aid training & fire fighting training should be given to persons working in chemical testing laboratory.5.2 化学药品和溶剂的有效性：Val

11、idity of chemicals and solvents：5.2.1固体化学药品的有效期是从接收之日起五年内。Validity period for solid chemicals is five years from the date of receipt.5.2.2液体化学药品的有效期是从接收之日起三年内。Validity period for liquid chemicals is three years from the date of receipt.5.2.3确保内部的有效期不能超过生产商的有效期限， 如果生产商的有效期限早于内部的有效期， 那么生产商的有效期限就是有效期。E

12、nsure that the In-house Validity should not exceed the manufacturers expiry date. If manufacturers expiry date is earlier than in-house validity period, then manufacturers expiry should be considered as validity period.5.3 化学药品和溶剂的接收和分发：Receipt and Issue of Chemicals and Solvents: 5.3.1相关QC人员需要亲自去检验

13、容器是否完整，接收的物质的标签是否正确。Concerned QC personnel should physically verify the intactness of container and correctness of label of received material.5.3.2如果发现问题，报告给QC经理或其授权人。If any discrepancy is observed, report to QC Manager or his designee.5.3.3把所有的化学物质和溶剂储存在指定的地方和储存条件（遵循生产商对储存条件的说明）。Store all chemicals

14、 and solvents in designated area and storage condition (follow manufacturers instruction for storage condition.5.3.4相关的QC人员需要填写化学药品和溶剂的库存和消耗的详细信息，依照附件-I。Concerned QC personnel should enter the necessary details in stock and consumption record of chemicals and solvents as per Annexure-I.5.3.5粘贴“化学药品的

15、接收/打开 ”标签（附录-II），在每个包装上填写必要的相关信息，比如接收日期、有效期至。Affix the label of “Chemical Receipt/Opening” (Annexure-II and enter the necessary details such as date of receipt and use before date on each container.5.3.6把化学药品和溶剂储存在指定的架上。Store the chemicals/solvents on designated racks.5.3.7当从库存里拿出化学药品和溶剂时，在化学药品库存和消耗

16、表中应填写相关的条目，在化学药品接收/开瓶的标签中填上打开的日期。While taking out the chemicals/solvents from the stock, necessary entries should be made in chemical stock and consumption format and put date of opening on chemical receipt/opening Label.5.3.8在使用前，使用者需要确认化学药品和溶剂的性质和外观。User should ensure the physical appearance or ch

17、aracteristics of chemicals and solvents before use.5.4 处理易燃溶剂的程序：Procedure for handling of flammable solvents:5.4.1在处理易燃溶剂时，要确保灭火器在旁边。While handling flammable solvents, ensure that fire extinguisher is nearby. 5.4.2使用水浴或金属加热板来蒸发易燃溶剂。Use water bath or heating plate for the evaporation of flammable so

18、lvents.5.4.3在通风橱房间里进行加热操作。Carry out heating operation in fumehood.5.4.4避免吸入烟或水挥发物。Avoid inhalation of fumes or vapors.5.4.5使用适当的工具来打开瓶子。Open the bottles with appropriate tools.5.4.6完工之后，马上用充足的水来排干溶剂。Drain the solvents with plenty of water immediately after completion of work.5.4.7在蒸馏的时候，确保冷凝器的进出水管安装

19、正确，并且有持续的水供应。During distillation, ensure that the water tubing to condenser is fitted properly and continuous water supply is in place.5.4.8在蒸馏或煮沸操作时，加些玻璃珠来避免暴沸。Add glass beads during distillation or boiling, to avoid bubble formation.5.5 处理酸碱的程序：Procedure of handling Acids/ Alkalis:5.5.1把浓的酸碱瓶子放在通风

20、橱里。Keep concentrated acid/alkali bottles located in cupboard of fumehood.5.5.2当稀释浓酸时，总是把酸缓慢地加到水中，同时不断搅拌。While preparing dilute acids from concentrated acids, always add acid drop wise to water with stirring by glass rod.5.5.3在冰浴中稀释浓酸/碱。Cool the contents of flask in ice bath while diluting concentrat

21、ed acids/alkalies.5.5.4避免和皮肤的直接接触。Avoid direct contact with skin.5.5.5假如不小心溅到皮肤上了，用充足的水冲洗被伤到的皮肤。In case of direct contact, pour sufficient water on affected skin. 5.5.6完工之后，马上用大量的水排干溶液。Drain the solutions with plenty of water immediately after completion of work.5.6 处理溴的程序：Procedure for handling bro

22、mine:5.6.1在打开溴的小瓶前，把它放在冰浴中冷却。Bromine vial should be chilled in ice-bath before opening.5.6.2把所有小瓶中的内容物转移到装有水的玻璃瓶中，然后盖紧瓶子。Transfer all the contents of vial into glass bottle containing water and close the bottle tightly.5.6.3不要把溴置于打开的小瓶中。Do not keep bromine in open vial.5.6.4在通风橱里进行稀释和实验。Carry out di

23、lution/experiment in fumehood.5.6.5不要吸入挥发物。Do not inhale vapors.5.6.6避免和皮肤的接触。Avoid contact with skin.5.6.7万一溅到皮肤上了，用大量的水冲洗受伤的皮肤。In case of direct contact, pour sufficient water on affected skin.5.6.8完工之后，用大量的水立刻排干溶液。Drain the solutions with plenty of water immediately after completion of work.5.7 处

24、理氨水溶液的程序：Procedure for handling ammonia solution:5.7.1在打开瓶子前，先冷却瓶子。The bottle should be chilled before opening.5.7.2用完之后，马上盖紧瓶子，放在冰箱里。Close the bottle promptly after use. Store it in refrigerator.5.7.3在通风橱的房间里进行稀释和实验。Carry out the dilution/experiment in fumehood.5.7.4不要吸入挥发物。 在处理的时候，要使用安全护目镜。Do not

25、inhale vapors. Use safety goggles while handling.5.7.5避免和皮肤的接触。Avoid skin contact.5.7.6万一溅到皮肤上了，用大量的水冲洗受伤的皮肤。Pour sufficient water on affected skin in case of direct contact.5.7.7完工之后，用大量的水立刻排干溶液Drain the solutions with plenty of water immediately after completion of work.5.8 处理有毒物质和乙酸酐的程序：Procedure

26、 for handling poisonous materials and acetic anhydride:5.8.1要很小心地处理有毒的物质。Handle all poisonous materials with care.5.8.2在处理的时候，使用一次性口罩，安全护目镜和一次性手套。While handling, use disposable masks, safety goggles and disposable hand gloves.5.8.3把所有的有毒物质放在单独的架上，并锁上。Store all poisonous materials in the separate rac

27、k under lock and key.5.8.4不要吸入有毒的烟。Do not inhale poisonous fumes.5.8.5使用完后，正确地把容器密封好。After use, seal the container properly.5.8.6避免和皮肤的接触。先用解毒剂冲洗溅到的皮肤，然后用水冲洗。Avoid contact with skin. Rinse splashes on the skin with antidote solution followed by water. 5.8.7在清洗已使用过的玻璃器皿时，得先用解毒剂溶液冲洗。Used glassware sho

28、uld be rinsed with antidote solution before sending it for washing.5.8.8处理溢出的溶剂和酸。Handling of spilled solvents and acids.5.8.9切断所有可能引起燃烧的源头。Cut all possible sources of ignition.5.8.10指导其他的QC人员对受污染区域保持一段安全的距离。Instruct other QC personnel to keep a safe distance from the spillage area.5.8.11戴上护目镜，鼻面具和手套，用大量的水和拖把清扫溢出的物质，然后当废物处理。Wear goggles, nose mask