申报者须知要求提交一份声明，由QP签字，保证所使用的原料药是根据GMP生产的。我产品中使用的原料药被广泛应用，但通常并不作为医药活性物质来使用，我要确认GMP符合性有些困难。我要怎样完成所要求的声明呢？
The notice to applicants requires the submission of a declaration signed by the qualifiedperson (QP) that the active substance used is manufactured in accordance with GMP. The active substance in my product is widely used, but not normally as a pharmaceutical active substance, and I am having some difficulty in confirming compliance. What should I do to furnish the required declaration?
1 回答
生产许可持有人有法定责任来保证成品药和活性物质完全符合GMP要求。我们也认识到有少量的药品，其原料药的基本用途并不是药用，因此生产商可能并不会追求符合制药行业客户的特定要求。对于他们来说，这部分业务量并不多。
一般来说应寻求替代资源，但在例外情况下，生产许可持有人应评估并记录GMP符合种程度，并提供基于风险的评估来对降低要求进行论证。
由QP提供的声明应详细说明所实施的标准可以提供与GMP相同程度的保证。欧洲药品管理局将通过这个途径收集经验，用以将来指南修订相关的讨论。
Full compliance with GMP for finished products and active substances is a legal obligation for manufacturing-authorisation holders. It is recognised that for a small number of medicinal products, the primary use of the active substance is not in a medicinal product and the producer may therefore not be aiming to meet the specific requirements of pharmaceutical customers that represent aninsignificant volume of business.
Alternative sources should normally be sought, but in exceptional circumstances the manufacturing-authorisation holder should assess and document to which extent GMP is complied with and provide a risk-based justification for the acceptance of any derogation.
The declaration provided by the QP should set out in detail the basis for declaring that the standards applied provide the same level of assurance as GMP. The European Medicines Agency will collect experience with this approach, which can be used as a basis for discussion on related amendments to guidelines in the future.
