保濟丸事件揭示本港中成藥規管漏洞百出，衞生署決定巡查全港 500間中成藥製造商，「如果冇改善空間，咁就要結業。」業界估計，如按 GMP（生產質量管理規範）標準，本港或有七至八成藥廠最終因達不到要求而結業。
什麼是GMP（生產質量管理規範）?
什麼是GMP（生產質量管理規範）?
2010-03-30 5:34 pm
回答 (2)
2010-04-06 5:56 am
✔ 最佳答案
《良好生產規範》（英語：Good Manufacturing Practice，簡稱：GMP）是指導食物、藥品、醫療產品生產和質量管理的法規。世界衛生組織於1975年11月正式公布GMP標準。國際上藥品的概念包括獸藥，只有中國和澳洲等少數幾個國家是將人用藥GMP和獸藥GMP分開的。 GMP香港翻譯為「生產質量管理規範標準」，香港擁有GMP認證的中成藥製造商只有七間：
‧維特健靈
‧和興白花油
‧香港生物科技研究院
‧北京同仁堂
‧香港康恩堂
‧余仁生（香港）
‧位元堂
◆藥品生產質量管理規範◆
http://zh.wikisource.org/zh-hant/%E8%8D%AF%E5%93%81%E7%94%9F%E4%BA%A7%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83#.E7.AC.AC.E4.B8.80.E7.AB.A0_.E6.80.BB.E5.88.99
參考: Google大神＊維基百科
2010-03-30 7:22 pm
GMP are manufacturing guidelines address issue that are consider potential hazardous for food, drug, medical device, or blood product to the public. For example, the products may need to be assemble in a clean area.
Is GMP standard going to guarantee safety to public?
No. A good example was the case with Europharm. I believe that they manufactured some products that were compromised with fungus a couple of years ago. they were GMP certified manufacturer, yet the guideline did not cover the manufacturer fault.
Is GMP standard going to guarantee safety to public?
No. A good example was the case with Europharm. I believe that they manufactured some products that were compromised with fungus a couple of years ago. they were GMP certified manufacturer, yet the guideline did not cover the manufacturer fault.
收錄日期: 2021-04-29 00:02:18
原文連結 [永久失效]:
https://hk.answers.yahoo.com/question/index?qid=20100330000051KK02222