美国CGMP文件--记录管理SOP

http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 毒手药王 QQ：442989057 http://www.ouryao.com/forum.php?fromuser=%B6%BE%CA%D6%D2%A9%CD%F5 http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 文件题目 Document Title 记录管理 SOP SOP – Record management 文件编号 Document Code 文件版本号 Version Code 00 (2011) 文件种类 Category of Document 管理类 Management 发放部门 Department of Issue QA 人员 Person 类别 Category 姓名/职位 Name /Position 签名 Signature 日期 Date 编写人 Compiled by 审核人 Check by 批准人 Approved by 生效日期 Valid from 文件分发部门：（ ） Department of document distributed: 序号 Serial No. 部门名称 Department Name 房间号 Room No. 负责人 Manager 1 2 3 4 5 6 7 8 9 10 11 12 http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 13 文件变更历史： History of document changing: 版本号 Version Code 变更日期 Changing Date 变更内容摘要 Abstract of Changing Contents 00 (2011) 2011.05.16 建立文件 File foundation http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 1 目的 Aim 规范记录的管理程序。 To standardizes the management procedures of records. 2 范围 Scope 本 SOP 适用于公司记录的发放、填写、审核、归档、保存、回收销毁等程序。 This SOP is apply to the distribution, filling, checking, filing, saving, recalling and destroying procedures of record of company. 3 职责 Responsibility 3.1 QA 部作为公司记录的主要管理部门，负责本 SOP 的制定及更新。 QA department is responsible for creating and updating this SOP as the mainly management department of company’s record. 3.1 各操作部门负责在操作的同时及时、真实地填写原始记录，并进行整理。 The operate departments are responsible for filling the original records timely and factually when operating, and neatening of the records. 3.3 各部门负责归档保存本部门的管理记录。 Departments are responsible for filing and saving the management record of their departments. 3.4 QA 部负责保存与产品相关的记录，包括批生产记录、批检验记录、产品放行记录、投诉和召回记录等。 QA department is responsible for saving the product-related record, including the batch production record, batch test record and complain and recall record. 4. 内容 Content 4.1 发放 Delivering 4.1.1 批生产记录的发放 Delivering of Batch Production Record 由使用部门的车间负责人或工艺员，按生产指令在生产前到文件管理 QA 处领取，由 QA 文件管理员利用该文件的原 件在 QA 文件资料室进行复印，在复印件的每一页下方用盖上蓝色流水号。流水号的编制方式如下：S+年份后两位+ 月份+三位流水号，如 2011 年 01 月第一次使用的批生产记录，应编号为：S1101001，第二次使用的记录编号为 S1101002，以此类推。如遇到设备故障或停电等原因暂停生产的，要及时收回未使用的记录，并进行登记。QA 在发 放和收回记录时要及时登记《批生产记录发放、收回登记表》（附录 1）。 For the delivery of batch production records, workshop header or process controller of using department receive the record with blue serial number on the below of each page according to manufacture order before the production. The record is copied by document management QA with the original document in document room of QA department. The formation of http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 serial number is like below: “S+ the behind two numbers of year + the behind two numbers of month + three following number”. For example, the first used batch production record in Jan. 2011 should be numbered as S1101001, the second used batch production record in Jan. 2011 should be numbered as S1101002, and so on. If the production would be stopped by the reasons of equipment fault or stopping source, the unused records should be recalled at once and registered. QA should register “Recall and delivery register account of batch production records” timely when delivery and recall records, see annex 1. 4.1.2 批检验记录的发放 Delivering of Batch Test Record 对于批检验记录的发放，由 QC 负责人指定专人，按生产指令或请验单到文件管理 QA 处领取，由文件管理 QA 利用 该文件原件在文件管理室复印出来，在记录的每一页下方用盖上流水号。流水号的编制方式如下：X+年份后两位+ 月份+三位流水号。成品批检验记录 X 应为“C”；中间产品批检验记录 X 应为“Z”；原料批检验记录 X 应为“Y”；辅料 批检验记录 X 应为“F”；包材批检验记录 X 应为“B”；介质的批检验记录 X 应为“J”。如 2011 年 01 月第一次使用的 成品批检验记录，应编号为：C1101001，第二次使用的记录编号为 C1101002，以此类推。如遇到设备故障或停电等 原因暂停生产的，要及时收回未使用的记录，并进行登记。QA 在发放和收回记录时要及时登记《批检验记录发放、 收回登记表》（附录 2）。 For the delivery of batch inspection records, someone specified by QC header receive the record with blue serial number on the below of each page according to manufacture order or Application list .The record is copied by document management QA with the original document in document room of QA department. The formation of serial number is like below: “X+ the behind two numbers of year + the behind two numbers of month + three following number”. For finish product batch inspection record, “X” should be “C”; For intermediate product batch inspection record, “X” should be “Z”; For API batch inspection record, “X” should be “Y”; For excipient batch inspection record, “X” should be “F”; For package material batch inspection record, “X” should be “B”; For media batch inspection record, “X” should be “J”. For example, the first used finish product batch inspection record in Jan. 2011 should be numbered as C1101001, the second use d finish product batch inspection record in Jan. 2011should be numbered as C1101002, and so on. If the production would be stopped by the reasons of equipment fault or stopping source, the unused records should be recalled at once and registered. QA should register “Recall and delivery register account of batch inspection records” timely when delivery and recall records, see annex 2. 4.1.3 确认/验证记录的发放 Delivering of Qualification/Validation Record 由确认/验证负责人到文件管理 QA 处领取，QA 文件管理员利用该文件的原件在文件资料室复印出来，在记录的每 一页下方用盖上流水号。流水号的编制方式如下：Q+年份后两位+月份+三位流水号。如遇到设备故障或停电等原因 暂停验证的，要及时收回未使用的记录，并进行登记。QA 在发放和收回记录时要及时登记《确认/验证记录发放、 收回登记表》。 For the delivery of qualification/validation records, the responsible person of qualification/validation receive the record with blue serial number on the below of each page. The record is copied by document management QA with the original document in document room of QA department. The formation of serial number is like below: “Q+ the behind two numbers of year + the behind two numbers of month + three following number”. If the qualification/validation would be stopped by the reasons of equipment fault or stopping source, the unused records should be recalled at once and registered. QA should register “Recall and delivery register account of qualification/validation records” timely when delivery and recall records, see annex 3. http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 4.1.4 各部门管理记录的发放 Delivering of Management Record of Departments 由各部门文件负责人员到文件管理 QA 处领取，文件管理 QA 根据文件的原件进行复印，在每一页盖上流水号，计数 发放。流水号的编制方式如下：年份后两位+月份+三位流水号。由于管理记录的使用量大，使用频繁，故一次发放 一个月使用量以上，登记《部门管理记录发放记录》，并由每个月初由现场 QA 核实上个月部门管理记录的剩余情况， 再由部门文件负责人员进行补领。《部门管理记录发放记录》应由各部门自行保管，领用时凭该表及 QA 确认情况进 行补领。 The administrator of each department receive the records at document manage QA. The record is copied by document management QA with the original document in document room of QA department. Each page of the copy must be stamped a serial number like below: “the behind two numbers of year + the behind two numbers of month + three following number”. The records should be released more than a month usage amount because they are frequently used. Fill the “Delivering Record of Department management Record”. At the beginning of each month, site QA inspector should check the surplus record last month, and the department document administer receive the new record again. The “Delivering Record of Department management Record” should be saved by departments them self, receive new record with this sheet and QA’s confirmation. 4.1.5 状态标识、标签等，由于其印制量大，故应对其印制量及发放加以控制，实行部门负责人、管理人员、操作工 分级控制，由使用部门根据批指令分次分批发放。原件应全部留存，使用过程中出现的废件要妥善管理保存，不得 随意丢弃，最后交由现场 QA 进行销毁。现场 QA 要认真检查督促。 The printing quantity must be recorded and delivery of state signs and labels because the large number of printing. It is necessary to implement stepping control by the head of related – department, managerial staff and operators. All original documents must be saved. We have to manage and save the defective documents which are generating when using properly and cannot reject optionally. Then hand these defective documents to QA in site to destroy. QA in site should inspect and supervise seriously. 4.2 填写 Filling out 4.2.1 本公司的原始记录（包括文件的签名），统一使用蓝色不褪色的碳素中性笔填写。 Consistently use blue carbon gel pen which will not fade to fill out original records (including the signature of document) of the Company. 4.2.2 记录应由操作人在操作的第一时间真实、及时地填写，不得事后补填。填写记录应字迹清晰、易辨别，不得容 易混淆。填写记录应完整，不得有“见….”、“同上”之类的填写方式。 Record shall be the first operator in the operation time is true, complete and timely manner, no later filling complement. Complete records shall be legible and easy to identify, not confusing. Complete records should be complete and no "see .... ", "ditto " fill in like manner. 4.2.3 品名等应写全名并按标准名填写，不可写简名。 Product Name should be full written according to standardized name, not to write simple name. http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 4.2.4 签名要签写全名，不得简写，不得盖印代替。 Sign the full name, not short name, not instead by stamping. 4.2.5 数据的修约应采用舍进机会相同的修约原则，即“4”舍，“6”入，“5”留双。 The revision of the data should adopt the principle “Banker's Rounding” 4.2.6 按 表格 关于规范使用各类表格的通知入职表格免费下载关于主播时间做一个表格详细英语字母大小写表格下载简历表格模板下载 内容填写齐全、数据完整，除备注外，不得留有空格，如无内容可填写，可对角划斜线表示。 Complete the form filled by the content, data integrity, in addition to Notes, shall not leave a space, such as no content can be filled, can draw a diagonal slash said. 4.2.7 记录填写错误时，填写人不得用涂改液涂改或用笔涂黑后涂改。应用笔在原数据或文字上轻划一条横线，然后 在旁边写上正确的数据或文字。并在修正处签上姓名和日期。原数据或文字应仍清晰可辨认。数据需更改时应整体 划线，不能只更改局部。如“2：30”须改为“14：30”时，应为“2：30 14：30”，而不能为“14 2 ：30”。 Fill in the error log when completed shall not be altered with correction fluid or a pen to blacken after the alterations. Use a pen to draw a horizontal line on the original data or text light, and then write the correct data or text by its side. And sign in name and date at amendment. Original data or text should remain clearly identifiable. The overall need to change the data should be crossed, not just change the part. Such as "2:30" to be changed to "14:30", the should be"2：30 14：30", but not for the "14 2 ：30. " 4.2.8 记录填写完成后，应及时汇总，交给部门负责人。 After the completed record shall be promptly collect to the department head. 4.3 审核 Checking 4.3.1 各部门管理人员负责对本部门的管理记录进行审核。 Administrative staff of each department is responsible for checking of the management record. 4.3.2 确认/验证部门负责对本部门的确认/验证记录进行审核。 Qualification/validation departments are responsible for checking of the qualification/validation records of their departments. 4.3.3 生产技术部负责对批生产记录进行审核，QC 部负责对批检验记录进行审核。 P and D department is responsible for checking batch production records; QC department is responsible for checking batch inspection records. http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 4.3.4 QA 负责对批记录（包括批生产记录、批检验记录）、确认和验证记录及各部门的关键管理记录进行审核。其中 批记录的审核程序参考《批记录管理 SOP》（编码： ）。 QA is responsible for checking of batch records (including batch production record and batch inspection record), qualification/validation record and the critical management record of departments. The checking procedure of batch record see “SOP - Management of batch records” (Code: ). 4.4 归档、销毁 Filing and destroying 4.4.1 设备 工程 路基工程安全技术交底工程项目施工成本控制工程量增项单年度零星工程技术标正投影法基本原理 部负责保存与设备相关的记录。和设备相关的记录，可作为设备档案的一部分。使用部门按年将每台 设备的使用、内部校正记录、确认记录等汇总后，交给设备工程部，作为该设备的档案存档保存。设备记录保存至 该设备报废。当设备报废时，该设备相关的设备记录，应由设备工程部填写《记录销毁申请单》，向 QA 部提出申请， 经 QA 负责人及主管领导批准后销毁，同时应完成《记录销毁登记表》。 Equipment department is responsible for saving the equipment related records. Equipment related records can be used as part of equipment files. The using departments collect the use and internal calibration records, qualification records of every equipment, deliver to Equipment department and save as this equipment’s file. The equipment file must be saved till the equipment is scrapped. When the equipment is scrapped, Equipment department should fill “Application for Destructing Record”, deliver it to QA department. After approved by Head of QA and vice-manager, the equipment related records must be destroyed and “Destruction Register of Record” must be finished at the same time. 4.4.2 和产品相关的记录，包括批生产记录、批检验记录、批放行记录、产品投诉处理记录、不良反应记录、确认/ 验证记录等，由 QA 负责归档保存。其中批记录的归档保存参考《批记录管理 SOP》（编码： ）。上述 记录保存至该批产品有效期后一年。如果该产品有效期加一年仍不足五年，记录应保存至少五年。超过保存期后， 由文件管理 QA 填写《记录销毁申请单》，向 QA 部提出申请，经 QA 负责人及主管领导批准后销毁，同时应完成《记 录销毁登记表》。 QA is responsible for filing and saving the product-related records, including batch production records, batch inspection records, batch release records, product complaint records, adverse reaction records, qualification/validation records. The filing and saving of batch record see “SOP - Management of batch records” (Code: ). These records must be saved till one year after the production expiry date. If the production expiry date is less than 4 years, the records must be saved for at least 5 years. When exceed the saving period, the document management QA fill “Application for Destructing Record”, deliver it to QA department. After approved by Head of QA and vice-manager, the equipment related records must be destroyed and “Destruction Register of Record” must be finished at the same time. 4.4.3 部门管理记录由各部门按年度负责归档保存，保存时间一般为三年。超过保存期后，由本部门填写《记录销毁 申请单》，向 QA 部提出申请，经 QA 负责人及主管领导批准后销毁，同时应完成《记录销毁登记表》。 The management records of departments should be filed and saved by related department by year, and the saving time is ordinary 3 years. When document exceed the saving period, the department should fill “Application for Destructing Record”, deliver it to QA department. After approved by Head of QA and vice-manager, the equipment related records must be destroyed and “Destruction Register of Record” must be finished at the same time. http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 4.4.4 失效记录 Invalid records 在文件生效时，发放到各部门前应收回失效版本的文件。详见《文件的印制、发放、保管、收回及销毁 SOP》（编 码： ）。当文件中包含记录，文件管理 QA 应将已发放到现场的失效的空白记录收回，核对记录 编号、发放数量等，在其它 QA 的监督下进行销毁，同时应完成《记录销毁登记表》。 When new version document come into force, the invalid version document must be recalled before delivering the new version. See “SOP - Printing, delivering, keeping, recalling and destruction of documents” (code; ). If there are records included in the document, document manage QA must recall the invalid blank records which are already delivered to site, check the record number and amount and etc. Destroy the records under the supervising of another QA, and fill the “Destruction Register of Record” at the same time. 5 附录 Annex 附录 1：《批生产记录发放、收回记录》 编码： Annex 1: Delivering and Recalling Record of Batch Production Record 附录 2：《批检验记录发放、收回记录》 编码： Annex 2: Delivering and Recalling Record of Batch Inspection Record 附录 3：《确认、验证记录发放、收回记录》 编码： Annex 3: Delivering and Recalling Record of Qualification/Validation Record 附录 4：《部门管理记录发放记录》 编码： Annex 4: Delivering Record of Department management Record 附录 5：《记录销毁 申请表 食品经营许可证新办申请表下载调动申请表下载出差申请表下载就业申请表下载数据下载申请表 》 编码： Annex 5: Application for Destructing Record 附录 5：《记录销毁登记表》 编码： Annex 5: Destruction Register of Record 生效日期： Valid from: 版本号： 00 Version code: 页码： 1/1 Page No.: 批生产记录发放、收回记录 Delivering and Recalling Record of Batch Production Record 部门名称 Dept.： 年 year: 月 month: 发放 Delivering 收回 Recalling 发放日期 Date 记录名称 Record Name 记录编号 Record Code 份数 Copy 发放人 Delivered by 接收人 Received by 收回日期 Date 份数 Copy 收回人 Recalled by 记录审查 Record inspection □合格 Release □不合格 Reject 生效日期： Valid from: 版本号： 00 Version code: 页码： 1/1 Page No.: 批检验记录发放、收回记录 Delivering and Recalling Record of Batch Inspection Record 部门名称 Dept.： 年 year: 月 month: 发放 Delivering 收回 Recalling 发放日期 Date 记录名称 Record Name 记录编号 Record Code 份数 Copy 发放人 Delivered by 接收人 Received by 收回日期 Date 份数 Copy 收回人 Recalled by 记录审查 Record inspection □合格 Release □不合格 Reject 生效日期： Valid from: 版本号： 00 Version code: 页码： 1/1 Page No.: 确认、验证记录发放、收回记录 Delivering and Recalling Record of Qualification/Validation Record 部门名称 Dept.： 年 year: 月 month: 发放 Delivering 收回 Recalling 发放日期 Date 记录名称 Record Name 记录编号 Record Code 份数 Copy 发放人 Delivered by 接收人 Received by 收回日期 Date 份数 Copy 收回人 Recalled by 记录审查 Record inspection □合格 Release □不合格 Reject 生效日期： Valid from: 版本号： 00 Version code: 页码： 1/1 Page No.: 部门管理记录发放、收回记录 Delivering Record of Department management Record 部门名称 Dept.： 年 year: 月 month: 发放日期 Date 记录名称 Record Name 记录编号 Record Code 份数 Copy 发放人 Delivered by 接收人 Received by 记录审查 Record inspection □合格 Release □不合格 Reject 生效日期： Valid from: 版本号： 00 Version code: 页码： 1/1 Page No.: 记录销毁申请表 Application for Destructing Document 记录基本信息 Basic information of record 销毁原因 Reasons for destruction 销毁方法 Destruction method 销毁的最后期限 Deadline of destruction 提出销毁人 Requested / Applied by 日期 Date QA 负责人意见 Statement of QA manager 签名 / 日期 SIG / date 分管领导意见 Statement of related-manager 签名 / 日期 SIG / date 销毁人 Destructor 监督人 Supervisor http://www.ouryao.com 制药技术的传播者 GMP 理论的践行者 知识如氧气无处不在，沟通如呼吸轻松自然。 记录销毁登记表 Destruction register of record 记录名称 Title 记录编号 Code of rec