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.