应该是 有申报 ANDA 经验的企业都有习惯用的声明模板。

例如，（仅供参考，不能保证是符合最新符合要求的）

STATEMENT OF GMP

[Generic Company Name Inc. / Ltd.]

[Generic Company Name Inc. / Ltd.] certifies that the methods used in, and the facilities and controls used for, the manufacture, processing, packaging and storage of drugs at our [Generic Company Name Inc./Ltd.] manufacturing plant conform to Current Good Manufacturing Practice in accord with 21 CFR Parts 210 and 211.

 设施编号

(Signed GMP statement required for all processing, warehousing and testing sites.)