申请GMP认证需要具备的条件

2023-04-28 · 法默康

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不是任何企业都可以申请GMP认证,企业在申请前一定要做一些验厂咨询,多了解一些有关GMP验厂的知识,或者找专业的验厂辅导公司,做一次验厂辅导。企业要申请食品GMP认证,必须具备下列5个条件:

Not every enterprise can apply for GMP certification. Before applying, enterprises must do some factory inspection consultation to learn more about GMP factory inspection knowledge, or find a professional factory inspection coaching company to do a factory inspection coaching. To apply for food GMP certification, enterprises must meet the following 5 conditions:

(一)领有公司执照或商号之营利事业登记证者。

(1) Those who have obtained a company license or a profit-making enterprise registration certificate from a business name.

(二)领有经济部工厂登记证,并载有申请认证之产品项目者。

(2) Those who have obtained a factory registration certificate from the Ministry of Economic Affairs and bear the product items for certification.

(三)符合现行食品有关法令、食品工厂GMP通、专则及本规章有关规定者。

(3) Those who comply with current food related laws and regulations, GMP regulations for food factories, special rules, and relevant provisions of these regulations.

(四)从事分装或改装产品之厂商,得申请食品GMP认证,惟其分装或改装前之产品应先取得食品GMP认证。

(4) Manufacturers engaged in repackaging or modifying products may apply for food GMP certification, but their products before repackaging or modifying should first obtain food GMP certification.

(五)加工层次轻微之产品,得视同分装或改装产品。如判定困难时,得提请食品GMP技术委员会研议。

(5) Products with minor processing levels may be considered as packaged or modified products. If it is difficult to determine, it may be submitted to the Food GMP Technical Committee for discussion.

以上5点是企业必须具备的,也是GMP验厂通过的先决条件。

The above 5 points are mandatory for enterprises and also a prerequisite for passing GMP factory inspections.