1.0 Objective目的:

To provide the procedure of Good Control laboratory Practice to meet the requirements, laid down under good manufacturing practices.

提供良好的实验室操作管理规程以满足GMP的要求。

2.0 Scope范围:

This SOP covers premises, personnel, and practices and is applicable to Quality Control and ARD laboratory of Yichang Humanwell Oral Solid Dosage Plant.

本规程包含人员、活动场所和操作，适用于质量控制和ARD实验室。

3.0 Responsibility职责:

3.1 All QC and ARD Specialist shall be responsible to follow this SOP.

所有QC和ARD专员应遵循本SOP。

3.2 Department manager or designee shall be responsible to ensure the implementation of this SOP.

部门经理或指定人员应确保本SOP的实施。

4.0 Definition定义:

4.1 GMP: It provides a model on which to base a documented quality system and describes the practical activities and the controls which must be in place in order to be able to produce products which comply with their specification and are safe for use.

GMP：指基于质量体系文件提供的一种模式，描述实际的活动并对其进行控制以达到能生产符合质量标准和安全使用的产品的目的。

5.0 Procedure程序:

5.1 General Instructions 一般要求

5.1.1 Make sure the availability of correct written instructions before starting a task.

开始工作前应确保文件是正确并可用的。

5.1.2 Do not carry out a task for which the Analyst is not been trained or in which the Analyst is not competent.

严禁让未经培训或不能胜任的分析员执行工作任务。

5.1.3 During the testing, always follow the written instructions precisely. If any doubt occurs clarify with superior.

检验过程中，严格遵守文件说明。若有疑问应与上级领导一起讨论解决。

5.1.4 Check that the equipment and the materials that is being used are correct ones, as stated in the procedure.

检查规程中使用的设备和物料是准确的。

5.1.5 Check that the equipment is being used is clean.

检查设备是洁净的。

5.1.6 Always be guard for labeling errors.

时时警惕标签是否有误。

5.1.7 Maintain personal hygiene.

保持个人卫生。

5.1.8 Make clear accurate records of what was done online and the checks carried out.

对进行的活动应进行及时准确的记录并检查。

5.2 Premises 活动区域

5.2.1 Maintain the laboratory work area and instrument / equipment clean and tidy at all time.

在任何时候应维护实验室工作区域和仪器/设备的干净整洁。

5.2.2 Clean and disinfect the sterile and microbiological testing areas at the laid down frequency as per the relevant procedure.

无菌区和微生物检测区应按照相关规程规定的频率进行清洁和消毒。

5.2.3 Keep the passageways clear of any obstacles all the time.

保持通道的清洁和畅通。

5.2.4 Record the temperature of the laboratory twice in a day. (Morning and afternoon).

每天记录两次实验室温度（上午和下午）。

5.2.5 To the extent possible switch off all equipment after use at the end of the day or whenever not in usage.

尽量在下班前关掉已使用完毕或不使用的仪器。

5.3 Personnel 人员

5.3.1 Follow entry exit procedures wherever applicable.

任何时候都应遵守进出程序。

5.3.2 Always wear the white gown as applicable in the laboratory premises.

进入实验室前必须穿白大褂。

5.3.3 Adhere to the respective procedures for personnel clothing for entering into the microbiological testing area.

人员进入微生物检测区域应遵循相应的更衣规程。

5.3.4 Analysts shall perform analysis of samples after they are qualified in the relevant training and qualification procedure.

分析员只有经过相关的培训和资质认定合格之后才能进行样品分析。

5.3.5 Follow daily routine work plan as instructed by the supervisor / manager.

将主管/QC经理制定的日常工作计划作为工作指导。

5.3.6 Before leaving the laboratory completed the day’s work and report to supervisor.

离开实验室之前，应完成当日的工作并向主管报告。

5.4 Practices 实践

5.4.1 Safety 安全

5.4.1.1 Follow safety instructions carefully all the time.

遵守安全说明。

5.4.1.2 Wear safety apparels as applicable in the laboratory premises.

在实验区域应根据需要穿戴安全服。

5.4.1.3 Do not drink or eat in the laboratory.

严禁在实验室内饮食。

5.4.1.4 Use rubber bulb to pipette the solution and do not pipette the solution with mouth.

用洗耳球和吸液管吸取溶液，严禁用嘴吸取。

5.4.1.5 Do not handle samples with bare hands.

不得裸手操作样品。

5.4.1.6 Always do a visual check on electrical equipment before use, looking for obvious wear or defects.

在使用电力设备前，应先检查是否有明显的线路裸露或缺陷。

5.4.1.7 Avoid spillage of samples, chemicals, solvents and reagents and if it happens, organize to clean the area as quickly as possible by following general safety precautions such as wearing hand gloves, goggles and respirators wherever required.

避免样品、培养基、化学试剂、溶剂和试剂的溢出，如果发生，应按要求做好防护措施，如穿戴好手套、护目镜和呼吸器，并迅速组织清洁此区域。

5.4.1.8 Acids and Hazardous chemicals and solvents shall be handled in Fume hood area. Poisonous chemicals shall be stored in secured area.

应在通风橱中进行酸类试剂、危险化学品和溶剂的操作。有毒化学品应在安全区域储存。

5.4.1.9 Always wash your hands, before leaving the laboratory, unless or whenever required for personal hygienic use.

除对个人卫生另有要求外，应在离开实验室前清洗双手。

5.4.2 Documentation 文件

5.4.2.1 Ensure the availability of current versions of documents in the laboratory.

确保实验室的文件都是当前版本。

5.4.2.2 Formats for operational use shall be issued through proper control.

用于操作使用的表格需通过适当控制后才可以放行。

5.4.2.3 SOPs, Specifications, Test Method and logbooks must be maintained securely, at the workplace where it can be easily accessed.

标准操作规程、质量标准、检验方法和实验记录本必须妥善保管并在工作区易于获取。

5.4.2.4 All analytical work shall be carried out by referring to approved current version of documents such as Standard Operating Procedure, Specifications, Test Method, etc.

所有的分析工作都必须遵循已批准的当前版本文件，如标准操作规程、质量标准、检验方法等。

5.4.2.5 The certificates received from the vendor / manufacturer shall be reviewed by the supervisor for completeness and proof of verification of tests and results (wherever applicable), the supervisor shall put a stamp, sign with date as a part of review. For example like COA of Raw materials and Packaging materials, or any analytical reports received from other laboratory.

一旦从供应商/生产厂家处接收到证书，主管必须检查其完整性并核实测试项和结果（若适用），主管应盖章并签署姓名和日期。例如：原辅料和包装材料的检验报告，或者从其它实验室收到的检验报告。

5.4.2.6 All entries recorded in the document should be legible and readable.

文档中的所有记录应清晰可读。

5.4.2.7 Analytical data shall be recorded during analysis online.

进行在线分析时，应记录分析数据。

5.4.2.8 Update all relevant logbooks.

更新所有相关的实验日志。

5.4.2.9 Supervisor is responsible to review the completeness of logbook / register, the reviewer shall sign with date at the end of the every page, (wherever applicable).

主管需负责对已完成的实验日志进行复核，并在日志的每页页脚处签署姓名和日期（如果适用）。

5.4.2.10 Attach all relevant analytical raw data obtained from instrument / equipment with sign and date to the test record/ after labeling the same.

附上所有来自仪器的相关原始分析记录，并在检验记录上签上名字和日期/贴签后同样也须签名。

5.4.2.11 Protect all documents from spillage of chemicals/ solutions when performing analysis.

在执行分析的时候保护所有文件不被泄露的化学试剂/溶液污染。

5.4.3 Chemicals 化学试剂

5.4.3.1 Label all chemicals and readymade reagents upon receipt as per the procedure mentioned in the relevant procedure.

按照相关规程对接收的所有化学品和现成的试剂贴上标签。

5.4.3.2 Examine chemicals for any change in appearance or nature (Colour, lumping, clarity, liquefaction etc.) and discard.

检查化学品的外观或属性（颜色、结块、透明度、液化等）是否发生变化，若有变化应报废处理。

5.4.3.3 Check the validity period and discard all chemicals beyond validity period by following relevant disposal procedure.

检查试剂的有效期，并根据相关的处理程序，处理所有过期的试剂。

5.4.4 Glassware 玻璃器具

5.4.4.1 Use Class “A” category volumetric glassware (pipettes, burettes, and volumetric flasks).

使用级别 “A”的玻璃器具（刻度吸管、滴定管和容量瓶）。

5.4.4.2 Clean all the laboratory glassware by following relevant procedures.

参照相关的规程对实验室的玻璃器具进行清洁。

5.4.4.3 Store all cleaned and dried glassware in a dust free storage area.

将洗净干燥的玻璃器具存放在没有灰尘的贮存区域。

5.4.4.4 Use clean and dry glassware for analysis.

分析时使用干净、干燥的玻璃器具。

5.4.4.5 Check the glassware for any cracks before using them. If found remove from the usage.

在使用玻璃器皿之前必须检查是否破裂，如果发现要及时清除。

5.4.4.6 Glassware meant for Residual solvent analysis, can be dried continuously at a higher temperature to avoid any trace contamination.

用于残留溶剂检测的玻璃器皿，可以在高温度的条件下干燥避免任何微量污染。

5.4.4.7 To the extent possible rinse the glassware with the solvent or diluent, which is meant for analysis in case of critical test procedure such as Related Substances.

如果做关键测试时，比如有关物质，应用溶剂和稀释剂润洗玻璃器皿。

5.4.4.8 Remove all used glassware from workbenches and send for washing after the completion of analysis and reporting.

在分析报告完成后，将已用过的玻璃器具从实验台面上转移至待清洗区。

5.4.5 Instrumentation 仪器使用

5.4.5.1 Allot identification number to all analytical instrument / equipment.

所有分析用的仪器/设备都需要给定一个识别编号。

5.4.5.2 Maintain all equipment / instrument clean.

保持所有仪器/设备的清洁。

5.4.5.3 Maintain all analytical balances on a steady platform, away from air currents and vibrations.

将分析天平放置在一个稳固的平台上，远离气流和振动。

5.4.5.4 Ensure all equipment / instruments are qualified as per relevant protocols before putting into use.

使用前，参照相关方案报告确保所有的仪器/设备都是合格的。

5.4.5.5 Maintain all instrument / equipment under calibrated status.

所有的仪器/设备都已经过校验。

5.4.5.6 Prevent usage of the under maintenance instrument / equipment.

不得使用维修中的仪器/设备。

5.4.5.7 Ensure all liquid / gas chromatographic columns are numbered and the usage log was updated as per the procedure given in the relevant procedure.

按相关规程对所有液相/气相色谱柱进行编号，并及时更新使用记录。

5.4.5.8 Check the calibration status of equipment / instrument before use.

在使用前对仪器/设备的校验状态进行检查。

5.4.5.9 Update and display activity status boards.

实时更新仪器的状态牌。

5.4.5.10 Replace spent / discolored Silica gel or desiccants at appropriate times.

及时更换已耗尽/变色的干燥剂。

5.4.6 Testing 检验

5.4.6.1 For all quantitative measurements, weighing shall be performed in a specified range balances, those are qualified and calibrated.

进行所有定量测试前，应使用指定量程，经过确认并校验的天平进行称量。

5.4.6.2 Label all sample and standard preparations for all tests with at least details such as A.R.No., Solution name and appropriate replicate preparation number wherever applicable (in a suitable short form in case of space constraint but in an identifiable manner), sign and date with legible marker pen.

标记所有测试项需用的样品溶液和标准溶液，标签内容至少应该包括分析报告编号，溶液名称，制备数量（格式不需太长但能够识别），用清晰的记号笔签名并署上日期。

5.4.6.3 Use clean spatula / clean weighing paper or clean pipette for transferring the sample as applicable.

使用干净的药匙/称量纸或者干净的移液管来转移样品。

5.4.6.4 Wipe the tip of the burette and pipette before dispensing the withdrawn liquid.

在取出液体时擦拭滴定管和移液管的下端口。

5.4.6.5 Label all standard solutions, mobile phases according to the relevant labeling procedure.

按照相关标签规程对所有标准溶液、流动相进行标记。

5.4.6.6 Label vials of GC/ LC analysis using a legible marker pen for easy traceability during routine testing.

在日常检验的过程中，用清晰的记号笔在分析用GC/LC的小瓶上做易追溯的标记。

5.4.6.7 Label all known peaks such as peak due to blank, placebo, known impurities and analyte in chromatograms obtained during the testing.

标记色谱图上所有的已知峰，比如溶剂空白、辅料空白、已知杂质和分析物。

5.4.6.8 During chromatographic analysis, use blank determinations at appropriate intervals to confirm and ensure baseline stability verification and carry over contaminations.

色谱分析中，应在适当的间隔期内使用空白测定来证明和确保基线的稳定性和残留污染。

5.4.6.9 Label all reagents and volumetric solutions as per the relevant procedure.

根据相关规程对所有试剂和滴定液贴上标签。

5.4.6.10 Maintain sample and test / standard solutions under protective conditions if indicated in analytical test procedures.

确保样品和检验/标准溶液按照分析测试规程中规定的保存条件保存。

5.4.6.11 Handle all laboratory analytical standards as per the instructions given in the relevant procedure and the directions for use as given on the label.

根据相关规程的说明和标签上的使用说明管理实验室所有分析标准品。

5.4.6.12 During analysis, if any abnormal or unexpected event occurs, document the details and approved by the supervisor.

在分析中，如果有任何异常或突发情况出现，应记录详细信息并由主管批准。

5.4.6.13 Analysts shall immediately report any deviations, OOT and OOS to their Supervisor / Manager.

分析员应尽快向主管和经理报告所有偏差、OOT和OOS。

5.4.7 Storage 储存

5.4.7.1 Store all samples at designated storage area and designated storage temperatures throughout the time it is retained in the laboratory, until their destruction.

始终在实验室中的指定储存区域和储存温度下，储存所有样品直至销毁。

5.4.7.2 Place all standards, reagents and chemicals at the designated storage area after use.

使用完所有的标准品、试剂和化学品后将其放置在指定的储存区。

5.4.7.3 Reseal / close the sample bags / bottles immediately after use.

使用完后应立即重新密封/关闭样品袋/瓶。