| 1. | Responsible for retention sample and regularly check retention sample as the approved sop
负责留样程序，按程序定期检查留样。 |
| 2. | The retention samples of the drug product must be stored at the site that releases the drug product batch
制剂产品的留样必须保存在放行制剂产品批的工厂。 |
| 3. | Retention samples must be visually examined periodically , if required by local regulations or by regulations in the intended market
留样必须进行定期目检，如果当地法规或预期市场规程要求。 |
| 4. | Retention samples must be stored in a secure area under conditions that are consistent with the specified storage conditions of the material or product
留样必须保存在一个安全的区域，此区域的条件与物料或产品规定的贮存条件一致。 |
| 5. | Access to the retention samples must be limited to authorized persons . any withdrawal of material from retention samples must be authorized by quality assurance and documented
接触留样仅限于经授权的人员。从留样中取样必须由质量保证部批准并记录。 |
| 6. | If a registered drug product batch is split and packaged for different countries or in different presentations then limited retention samples must be held for each country or presentation unless there is a specific request from an individual country to retain full retention samples
如果一个经注册的制剂产品批次被分开，为不同的国家包装或不同的规格包装，那么留样必须按每一个国家或规格进行，除非有一个来自个别国家的具体要求保留全部的留样。 |
