不了解中国法规，仅谈一下美国法规的倾向，供参考。

美国FDA有一份指南有谈到到底是owner还是contractor的责任归属问题，见Contract_Manufacturing_Arrangements_for_Drugs_Quality_Agreements。

首先你作为外包商（contractor)，要检查一下你和owner（即MAH）签订的质量协议（quality agreement）是如何定义GMP活动事项和责任的，例如有没有具体规定谁负责原料药的审计。在GMP检查时，你不能用因为以前都是owner在对API审计的这种历史经验说服检查官，肯定要拿出一些具体依据的。

不过，再者，在指南末尾举的四个例子（Case 1, case 2, case 3, case 4)，具体谈到了几种owner和contractor的责任归属纠纷。其中，FDA对case 1 和case 2的态度，认为就算有质量协议在先，也不能豁免owner或contract facilities （即CMO）遵循cGMP要求的责任。

因此，从个人理解的角度，结合题者实际以及FDA的态度（见下面引用的原文，特别是加粗部分），倾向于认为contractor和owner均需要对API审计负责。而且就算是质量协议有明确规定的情况下，仍然不能免除contractor和owner要遵循cGMP要求的责任。

建议contractor尽早签订或者更新质量协议，明确谁是具体执行人。但是不管是contractor还是owner具体去执行审计，都是需要对符合cGMP负责的。

“In the cases described above, the owners and contract facilities appear to be in violation of CGMP. A quality agreement cannot exempt owners or contract facilities from statutory or regulatory responsibilities to comply with applicable CGMP, regardless of whether the quality agreement specifically discusses those CGMP requirements. In case 1, the contract facility violates CGMP requirements by continuing to manufacture on outdated or poorly designed equipment, even though the quality agreement says that the owner is responsible for maintenance and upkeep of the equipment. In case 2, the contract facility violates CGMP by using a batch record that does not accurately reflect the manufacturing process, even though the batch record is consistent with what was set out in the quality agreement.

At the same time, the owner remains responsible for ensuring its products are made in compliance with CGMP even when a quality agreement assigns a particular manufacturing activity to the contract facility. After finding problems at a contract facility, such as the ones described in the cases above, FDA might determine that it is appropriate to inspect the owner. The owner could also be in violation of CGMP related to its failure to oversee the contract facility’s manufacturing activities.”

欧盟有明确的要求，由MAH审计原料供应商，也可以是MAH委托的组织进行审计，所以他们想让你们管，那你们就找他们要钱，他们不给，你们就在文件规定好对于这种受托生产的产品，供应商审计如何开展。