一个新项目开始之后 ，我们该如何确保RLD信息的完整和可靠性 ，使最终得到的数据能够符合ANDA申请的要求呢？以下的Checklist可以帮助我们来一项一项检查：
| 1. Has the Reference Listed Drug (RLD) been chosen from the Orange Guide? |
| 参比制剂（RLD）是否选择自橙皮书？ |
| 2. Has the RLD been purchased in all the proposed marketing sizes ? |
| RLD是否从目标市场采购 ？ |
| 3. Have different batch numbers (3 lot #’s) of the RLD been purchased? |
| 是否采购了3批不同的批号？ |
| 4. Confirm if the RLD is of recent manufacture (analyze new samples)? |
| RLD是否是近期生产的 ？ |
| 5. Conform that at least 10-20 samples of each RLD lot # and pack size are available for physical, chemical (assay and impurities), dissolution and stability testing? |
| 是否至少每个RLD批号都有10-20片样品和包装规格可以用来进行物理的、化学的（含量和杂质）、溶出和稳定性研究？ |
| 6. Confirm if the RLD has been placed on stability at 40o C for 3 months for evalsuating potential degradation and impurity levels? |
| 是否RLD被放到40度3个月来考察降解和杂质水平？ |
| 7. Confirm if the impurity profile of the RLD has been evalsuated? |
| RLD杂质谱是否被考察过 ？ |
| 8. Has reverse engineering of the RLD formula been performed? |
| RLD的反向工程做过吗 ？ |
| 9. Have the chosen inactive and maximum strength been cross-checked in the IIG? (for unique or unusual excipients)? |
| 选择的辅料和最大用量有没有超出IIG限度（针对特别的或者不常用辅料） ？ |
| 10. Are the in-actives qualitatively compatible with the RLD for oral use (composition and strength)? |
| 是否做过定性的原辅料相容性？ |
| 11 Have the RLD formula been reviewed in the International Drug Compendia (Italian, French, Swiss) for formula composition data? |
| RLD的组成信息是否被国际药典审阅过 ？ |
| 12. Has the FOI system been used to gather data on the Innovative drug? |
| FOI系统是否被用来收集创新药的数据 |
| 13. Has a full analytical profile range been determined from analysis of the various batch lots of the RLD (at least 3 lots #’s for Assay; Content Uniformity; Impurities; Dissolution)? |
| 有完整的RLD批间差异的检测范围吗 ？ |
| 14. Has the chosen RLD undergone stress testing to establish the level of its degradation products? |
| RLD是否使用强制降解实验来确定降解产物的水平？ |
| 15. Has a multipoint dissolution of the several RLD batch lots been evalsuated to assess the consistency of the RLD dissolution parameters? |
| 是否使用多批号RLD进行多点溶出实验来评估RLD溶出参数的一致性？ |
