【原创】happyjyl的翻译（五）－－《现场核查及抽样参考要求》及相关表格和填写说明

1、接到现场核查通知书2日内，请申请单位将申报资料1套（包括申请表、受理通知书复印件各1份）及现场核查通知1份送至上海市食品药品检验所（张江张衡路1500号）业务科受理处，并提供联系人手机号码。
1. Submit a set of application dossier- including a hard copy of the application form and the acceptance letter respectively- and the on-site inspection notice letter within 2 working days of receipt of the on-site inspection notice letter to the Acceptance Office of the Business Department of SIFDC, located in 1500 Zhangheng Road, Zhangjiang Hi-tech Park. The mobile phone number of the contact person should be provided simultaneously.
注释：
Hard copy: 硬拷贝(由电子计算机，缩微胶卷等复制的无需专门设备即可阅读的打印件)。与之相反的是soft copy：软拷贝(显示在屏幕上的内容)。
收到……2日内：within 2 days of receipt of sth.由于这里的2日明显是指工作日，（比如星期五收到现场核查通知书，星期一才能递交资料。）所以译为within 2 working days.
SIFDC：上海药检所（Shanghai Institute for Food and Drug Control）的简称。

2、请申请单位负责联系安排现场核查人员的往返交通问题。
2. Arrange the round trip transportation of the inspectors.

3、现场核查及抽样的具体内容和程序要求请见国家食品药品监督管理局发布的《药品注册现场核查及抽样程序与要求（试行）》、上海市食品药品监督管理局发布的《药品注册现场核查及抽样须知》（可分别在国家食品药品监督管理局网站http://www.sfda.gov.cn法规文件栏和上海市食品药品监督管理局网站http://www.shfda.gov.cn公告通知栏下载）和国食药监注［2006］265号文。
3. The detailed contents and procedures of the on-site inspection and sampling can be found in Procedures and Requirements of On-site Inspection and Sampling for Drug Registration (Trial) issued by SFDA, Notice of On-site Inspection and Sampling for Drug Registration issued by SHFDA and the Decree No. [2006] 265 issued by the Drug Registration Division of SFDA. The first two can be downloaded at the Regulations Column of SFDA website http://www.sfda.gov.cn and at the Announcements Column of SHFDA website http://www.shfda.gov.cn.
注释：
译文中的斜体表示书名。英文里没有书名号，书名通常用斜体或单引号表示，并且除连词、冠词、介词之外所有单词的首字母要大写。
SFDA：国家食品药品监督管理局（State Food and Drug Administration）的简称。
SHFDA：上海食品药品监督管理局（Shanghai Food and Drug Administration）的简称。
“国食药监注［2006］265号文”姑且先翻译为Decree No. [2006] 265 issued by the Drug Registration Division of SFDA，因为它是SFDA药品注册司颁布的，不知道还有没有更好的译法。
我在这里用Column代表网站上的栏目，并且栏目的首字母大写。只是看到很多网站上是这样写的，并没有见过详细论述如何翻译的文章。大家有见到的话希望能上传给我借鉴借鉴。

4、药品研制所涉及的原始记录（包括原辅料检验、处方工艺研究、质量研究、稳定性研究、申报样品试制和检验、药理毒理研究等方面）应按《药品研究实验记录暂行规定》（国药管安［2000］1号）要求归档，参照附表7项目要求，须装订成册（可以线装、胶装、订书钉装等固定，不得采用活页装订或活页夹形式），列出内目录，并有连续页码编号。各试验项目尽可能合并装订。如有委托研究项目，亦应按上述要求提供原始记录，请事先与相关研究单位联系，做好协调工作。
4. File the original records- records of tests of APIs and excipients, formula and process research, quality research, stability study, pilot production and tests of the samples, pharmacology and toxicology study and so on- as required by Temporary Regulations on Experimental Records of Drug Research (Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA). Bind the records as required by Form 7. The records may be bound with thread, glue or staples, but not in the form of loose leaves. List the contents and number the pages. Try best to bind the records of an item together. Provide original records likewise for commissioned research and contact with relative research organizations beforehand to arrange things.
注释：
样品试制：pilot production或trial production
“（国药管安［2000］1号）”因为是SFDA安监司颁布的，所以翻译为Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA。

5、请在现场核查时提供已经准备好的下列文件。
5. Get the following documents ready and present them in the inspection.

（1）《药品研制情况申报表》复印件1份，并请对该申报表逐项详细核对，内容应填写完整，样品试制量栏用括号注明是否为最小量、半数量或最大量，末页在规定处签字盖章及填写日期。
(1) A copy of completely filled and thoroughly checked Drug Research Declaration Form. Indicate in brackets whether the quantity is minimum, half, or maximum quantity in the Pilot Sample Quantity Column. Sign, stamp and date where indicated on the last page.
注释：
“请对该申报表逐项详细核对，内容应填写完整，”这句话语序颠倒了，应该是先填写完整再详细核对，所以这里翻译为completely filled and thoroughly checked。
Where indicated：在注明处（即在规定处）。

（2）申报资料1套（包括申请表、受理通知书）。
(2) A set of application dossier, including the application form and the acceptance letter.

（3）《药品研制情况核查报告表》原件一式5份，以及复印件1份，其中第1页请打印填写表格的前3行（核查地址包括申报样品试制及质量检验地址），并按规定签字盖章。该报告表可在国家局网站或上海局网站公告通知栏下载。
(3) The original copy in quintuplicate and a hard copy of Drug Research Inspection Report Form. Fill in on computer the first three lines of the form and print. Include the site of pilot production and quality test in the inspection site. Sign and stamp where indicated. The form can be downloaded at the Announcements Column of SFDA or SHFDA website.
注释：
文件份数的表达方式：一式两份in duplicate；一式三份in triplicate；一式四份in quadruplicate；一式五份in quintuplicate；一式六份in sextuplicate；一式七份in septuplicate；一式八份in octuplicate；一式九份in nonuplicate；一式十份in decuplicate。
打印填写：我的理解是先在电脑上填写表格，然后把表格打印出来。（不是把表格打印出来后在现场核查时填写。）

（4）药品研制情况汇总表（见附表1-6）1套，申请单位应按要求根据实际情况将所有内容填写完整，现场核查时填写的部分（粗框）不需要填写，与表格设计不符合处可作出说明，并请被核查单位的负责人核实后签名和加盖公章。核查中发现与所提交的汇总表及研制情况申报表不一致的，根据情节严重程度，将被记入诚信档案。
(4) A set of Drug Research Summary Form (See Table 1-6), filled in truthfully and completely by the applicant except the bold-framed part remained for inspectors, indicated where the content does not comply with the designed forms, signed and stamped by the person in charge of the inspected organizations after checking. Inspection results not consistent with those in Drug Research Declaration Form and Drug Research Summary Form will be recorded in the credit file according to the severity.
注释：
“粗框部分”译为bold-framed part，“诚信档案”译为“credit file”。不知道这算不算Chinglish。

（5）预填的《原始记录核查及加封标识记录》（见附表7）1份。
(5) A copy of pre-filled Inspection and Ensealing Records of Original Records (See Form 7).

（6）药品研制所涉及的协议书、委托研究合同、委托研究报告书原件及复印件1份，被委托机构的合法登记证书及相关资质证明文件复印件1份。
(6) An original copy and a hard copy of agreements, commission research contracts and reports relating to drug research. A hard copy of legal registration certificate and relative qualification certificates of the commissioned organizations.

（7）药品研制全过程所涉及的物料（原料药、主要及专用辅料、对照品、参比制剂、包装材料、研究和检验专用试剂及材料和试验动物）的原始来源凭证（发票、付款凭证、收发货凭证、邮寄凭证等）原件及复印件1套；并提供相关台帐、物料收发原始凭证。其中试验动物等的原始凭证在其他研究单位难以在核查现场提供的，应提供其他研究单位盖章的复印件，及相应的清晰可辨的彩色数码照片供查。
(7) An original copy and a hard copy of original vouchers of materials involved in the whole drug research- APIs, main and specific excipients, reference standards, reference preparations, packaging materials, special reagents and materials for research and test, and experimental animals- including invoices, payment vouchers, consignment vouchers, receiving vouchers, mailing vouchers and so on. Provide relative accounts and original consignment and receiving vouchers of materials. If the original vouchers are kept in the research organizations and are therefore impossible to present on the inspection site, present the hard copy stamped by the research organizations and legible color digital photos.

（8）相关的仪器设备使用记录及存档电子图谱文件。
(8) Relative service records of devices and filed electronic spectra.

6、药品研制过程所涉及的各试验项目研究人员、样品试制、检验、质量保证负责人、药品注册负责人、机构负责人、相关的原材料、样品、各类原始记录、档案资料、票证凭据等的保管人员、财务人员在现场核查过程中应在岗，并按照现场核查人员的要求配合核查工作。所有相关人员需至检查现场亲笔签名。
6. Research staff, persons in charge of pilot production, test, quality assurance and registration, heads of the organizations, keepers of the APIs, samples, original records, files and credence, and finance staff should be on the inspection site and support the inspectors. All relative staff should be on site and sign in person.

7、被核查单位负责人应熟悉所报品种的研制情况，并应向现场核查人员汇报产品研制的基本经过、研制过程中需要说明的问题。对于实际情况与有关要求不完全相符，以及尚未按规定递交变更申请等问题，应提供加盖公章的书面汇报，并在药品研制情况汇总表相应位置备注栏作出标注。
7. The heads of the inspected organizations should be familiar with the research of the applied product and present to inspectors the process and questions subject to explanation. Present stamped written reports for problems such as failing to agree with relative requirements or to submit application for change as required and remarks in the Remarks Column of Drug Research Summary Form.
注释：
“Present stamped written reports for problems such as failing to agree with relative requirements or to submit application for change as required……”这里的to submit application是指problems such as failing to submit application for change as required。

8、现场核查人员可以向被核查机构的参加研究人员就申报品种相关情况进行询问。必要时，现场核查人员可以对研制现场的场地、设备、仪器以及相关文件、凭证和原始记录等进行照相或者复制，并要求被核查机构负责人在有关检查记录和复制件上签字盖章。
8. Inspectors may question the research staff on the applied product, take pictures or copies of the site, device, instruments, relative documents, credence and original records, and require the heads of the inspected organizations sign and stamp on the inspection records and copies when necessary.

9、请根据药品注册要求的抽样量准备好相适应的封样用包装，一般为每个批号2个独立外包装（分别为2倍和1倍检验用量），有特殊检验要求（如原料药无菌、热原、细菌内毒素等，应根据检验项目需要分装）。
9. Prepare appropriate packages to seal samples according to the drug registration requirements on sample quantities, generally two independent outer packages- for 2 and 1 times of the required quantity respectively. Repackage the samples for products with specific test requirements (such as sterile test, pyrogen reaction and bacterial endotoxin test for APIs).
注释：
分装：repackage

10、核查结束时申请单位及有关人员应根据核查人员的要求配合签名、盖章、提交相关文件及作必要的更正等，并将封签样品、药品抽样记录及凭证、与药品注册检验相关的申报资料，在抽样后5日内送达指定的药品检验所。
10. Sign, stamp, submit and make necessary corrections as required at the end of the inspection. Submit the sealed samples, sampling records and credence, and relative application dossier to the designated drug control institution within 5 working days of sampling.

附表填表说明
Instructions for Filling in the Forms

各附表系为保证现场核查工作顺利有序进行而制定，申请单位应当在现场核查之前按各表内容清理好供核查的各类材料及现场。表中设计的内容如与研制工作不匹配，申请单位可根据实际情况适当修改填写内容，并在备注栏作出说明。
The forms are designed to ensure the on-site inspection. The applicant should prepare materials and clear the sites for inspection beforehand and may modify the forms and indicate in the Remarks Column if the designed forms do not match the facts.

附表1：（1）类别：A原料（包括药品生产过程中需要使用细菌、病毒、酵母等微生物；制备产品必须的各类树脂、层析柱等关键物料），B辅料，C对照品，D上市参比制剂，E药包材，F专用试剂，G实验动物及细胞等其他材料；（2）要求提供使用的所有批次原料、对照品、上市参比制剂、专用辅料、专用试验试剂及药包材的来源凭证原件，登记数量、批号、购买日期，并根据有关帐册登记入出库时间及用量，根据实际存样登记实余量。
Form 1: (1) Category: A: APIs, including microorganisms (bacteria, virus, yeasts and so on) and key materials (resins, chromatography columns and so on) needed in the drug manufacturing process. B: Excipients. C: Reference standards. D: Marketed reference preparations. E: Drug packaging materials. F: Specific reagents. G: other materials such as experimental animals and cells. (2) Present original source vouchers of all the APIs, reference standards, marketed reference preparations, specific excipients, specific reagents and drug packaging materials. Fill in the quantities, batch numbers, purchase dates, warehousing dates, requisition dates, consumed quantities and remained quantities according to the account books and remained samples.
注释：
“根据实际存样登记实余量。”这句话里的“根据实际存样”说得多此一举，“实余量”里的“实”字就已经说明了它是照实际情况登记的。所以在翻译的时候我把“根据实际存样”去掉了。

附表2：（1）类别：1处方和工艺研究及小试样品，2质量和稳定性研究用样品，3药理毒理研究和临床用样品，4申报注册供抽样检验用样品；（2）根据实际存样登记实余量；（3）试制场地应填写该批号实际试制的具体房间或车间；（4）根据实际情况可调整表格设置，基本内容应不减少，不适用的栏目可填入“——”。
Form 2: (1) Category: 1. Pilot products for formula and process research. 2. Samples for quality and stability study. 3. Samples for pharmacology, toxicology and clinical study. 4. Samples for registration. (2) Fill in the actual remained quantity. (3) Fill in the exact room or workshop where the batches are pilot produced. (4) Applicants may modify the form and fill in “-” where not applicable but should not omit the basic contents.
注释：处方和工艺研究用的是小试样品，在质量和稳定性研究中小试、中试和大生产样品都会用到，所以在翻译时应注意把两者区别开。一个翻译为pilot products,一个翻译为samples。
“not applicable”经常写作“NA”。“NA”在实验报告中常用的意思有两个：“not applicable”（不适用）和“not available”（不可得）。所以如果在报告表格中写“NA”，应在表格下注明到底代表的是哪一个。

附表3：（1）类别：1实验室，2 非GMP车间，3 GMP车间，4其他；（2）主要配件填写配套使用的模具及型号；（3）连续生产无投料量及产量无限制的设备在最大量和半数量栏内填入“不适用”；（4）设备安放场地应写明具体房间号。
Form 3: (1) Category: 1. Laboratory. 2. Non-GMP workshop. 3. GMP workshop. 4. Others. (2) Fill in the fittings and their types in the Main Fittings Column. (3) Fill in “not applicable” in the Maximum Column and Intermediate Column if the input and yield quantities are not fixed for continuous production. (4) Fill in the number of the room where the devices are emplaced.
注释：
“主要配件填写配套使用的模具及型号；”这句话太口语化了，应该是“在‘主要配件’一栏里填写配套使用的模具及型号。”翻译时做了修改。
我对“连续生产无投料量及产量无限制”是这么理解的：因为一直在生产，不停地在投料，所以没有固定的投料量和产量。不知道这么理解对不对。

附表4：（1）类别：1质量研究，2 稳定性研究，3样品检验，4中间体检验，5原辅料检验，6药理毒理研究，7临床研究，8其他；（2）试验项目应按质量标准的检测项目，并按不同试验次数详细列出，不同次数情况雷同的可合并填写；（3）同一项检测项目涉及多个对照品及参比制剂的，应逐一列出名称及批号；（4）专用试验材料包括：专用试剂、实验动物、细胞、细菌、病毒等实验中用到的主要材料。
Form 4: (1) Category: 1. Quality research. 2. Stability study. 3. Sample analysis. 4. Intermediate analysis. 5. APIs and excipients analysis. 6. Pharmacology and toxicology study. 7. Clinical study. 8. Others. (2) For items described in the specification, list every test results. If a test is done 2 times or more, same results of different test times may be filled in one place. (3) List all the reference standards, reference preparations and corresponding batch numbers. (4) Specific test materials include specific reagents, experimental animals, cells, bacteria, virus and so on.

附表5：（1）类别：1质量研究，2稳定性研究，3注册样品检验，4 中间体检验，5原辅料检验，6其他；（2）设备安放场地应写明具体房间号；（3）主要附表包括：色谱柱及型号、多元泵、自动进样器、柱温箱、检测器等主要检测条件；（4）根据实际情况如无相应附表等应填写“无”。
Form 5: (1) Category: 1. Quality research. 2. Stability study. 3. Sample analysis. 4. Intermediate analysis. 5. APIs and excipients analysis. 6. Others. (2) Fill in the number of the room where the devices are emplaced. (3) Main attached tables include main test conditions such as names and types of chromatography columns, multi-pumps, automatic injectors, ovens, detectors and so on. (4) Fill in “Naught” if no table is attached.
注释：
根据实际情况如无相应附表等应填写“无”。－这句话里的“根据实际情况”也是多此一举，在翻译时去掉了。

附表6：（1）应包括与本品研究相关的所有参与人员，包括：单位负责人、项目负责人、注册负责人、质量保证负责人、物料采购及保管人员、档案及原始凭证保管人员；工艺研究、样品试制、质量研究、稳定性研究、原辅料、中间体及样品检验的操作及复核人员；药理毒理研究负责人及试验人员；（2）所有相关人员在现场核查当时已离职或不能出席的，应在备注栏写明离职或缺席原因。
Form 6: (1) Fill in all the staff involved in the product research, including: 1. Persons in charge of the organizations, the project, the registration, QA, materials purchase and keeping, files and original vouchers keeping. 2. Operators and checkers of process research, pilot production, quality research, stability study, API analysis, excipient analysis, intermediate analysis and sample analysis. 3. Leaders and operators of pharmacology and toxicology study. (2) Fill in “Turnover” or indicate the reason for absence if the relative person has resigned or is not available on the inspection site.

附表7：（1）凡申报资料涉及到进行了试验，应当有原始记录的项目，在“有／无”栏填写“有”；（2）“原始记录保存场所”应写明保存地址及部门；（3）“册号”为按试验单位内部规定编制的原始记录本编号；如果不同试验项目在同一册则填写同一册号及相应页码，同一试验项目有多册的则填写多个册号及所对应的页码；（4）个别原始资料无法装订的以及其他特殊情况，应在“备注”栏注明；（5）获国家局GLP认证证书单位的原始记录应登记，但不加封标识。

Form 7: (1) Fill in “Yes” for items under which tests have been done. (2) Fill in the address where original records are kept and the keeping department. (3) “Volume Sequence No.” refers to the sequence numbers of the original records. If records of different items are in the same volume, fill in the same sequence number and corresponding pages, otherwise fill in different sequence numbers and corresponding pages. (4) Indicate in the Remarks Column if some original records can not be bound or in other specific cases. (5) Original records of organizations which have obtained the GIP certificate from SFDA should be registered but not sealed.
注释：
“个别原始资料无法装订的以及其他特殊情况”我翻译成“Indicate in the Remarks Column if some original records can not be bound or in other specific cases.”。感觉in other specific cases用在这里使句子结构不对，但一时也想不出该怎么改。请ruojun和poorlittle给点建议。

Ruojun：To ensure successful implementation of on-site inspection and samplings for drug registration, applicants and relevant research institutions shall make relevant preparations.