法令2001/83/EC及修订内容（法令2001/82/EC兽药）指出生产许可持有人有义务仅使用根据GMP指南生产的活性物质作为起始物料。因此，法律将该责任赋予了使用该活性物质的生产许可持有人，而并没有要求对活性物质生产商进行强制的定期检查。

为了指导原料药生产商如何建立GMP合规性，本网站已公布了指南文件，包括“何时适合药监局对用作起始物料的原料药生产商进行现场检查指南”，这是欧盟程序的一部分。本文件指出，期望生产许可持有人一般要通过审计原料药生产商来保证其使用的原料药符合GMP要求。

另外，关于活性物质生产商审计的问答可在另一部分找到。

Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products)states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured in accordance with the detailed guidelines on GMP for starting materials. Thus the legislation puts the responsibility on the manufacturing-authorisation holders using theactive substance and does not foresee mandatory routine inspections ofactive-substance manufacturers.

To provide guidance on how GMP compliance of active-substance manufacturers should be established, guidance documents have been published on this website, including the 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials' as part of the Community procedures. This document states that it is expected that manufacturing-authorisation holders will normally gain assurance that the active substances it uses are manufactured inaccordance with GMP through audit of the active-substance suppliers.

In addition, anumber of questions and answers on audits of active-substance manufacturers on this page provide further guidance.