请问下Schedule-M certificate是个什么证书？

smartzhenygx

有客户要Schedule-M certificate，我们没有过国外的经验，不知道是个什么证书，请哪位给指点下迷经，客户还问是不是符合Schedule–M: Part IF，这又是个什么规定呢？

gmp-qc

http://cdsco.nic.in/html/gmp/schedulem%28gmp%29.pdf
我搜了一下，感觉就像GMP一样的，还有说是税单的，那个应该不是客户需要的。
如果能给出上下文就更好猜测了

beiwei5du

• Earlier Indian FDA was issuing the WHO- GMP certification but that  practice has ben abolished now under some objections from WHO. Now The  Indian pharma regulator has been issuing the Certificate of  Pharmaceutical Products (COPP) which is on par with the WHO-GMP  certificates. For the marketing of drugs within the country only  Schedule M certification is required.
  

这个是在印度国内销售药品的一个认证（相当于GMP），2009.09年前印度是实行的WHO-GMP，但是在后期自己COPP认证，所以对于国内药品销售就放弃了WHO-GMP认证，但是印度出口至国外COPP和WHO certificate则是必须均通过的。仅供参考，我也是一知半解。
That is, if they produce the DCGI's Certificate of Pharmaceutical Products (COPP), they can sell their brands in India. COPP and WHO certification are compulsory if the company wants to export, a government official, who asked not to be named, said. The DCGI would not issue WHO-GMP certificate to any company from now on.

http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/domestic-drug-makers-will-not-need-gmp-certificate/articleshow/4114266.cms
Schedule-M原文
http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf

smartzhenygx

gmp-qc 发表于 2016-9-20 17:26
http://cdsco.nic.in/html/gmp/schedulem%28gmp%29.pdf
我搜了一下，感觉就像GMP一样的，还有说是税单的， ...

谢谢回复！看了下跟GMP规定似的，最起码心里有底怎么回复客户了！非常感谢啊！！

smartzhenygx

beiwei5du 发表于 2016-9-20 20:10

Earlier Indian FDA was issuing the WHO- GMP certification but that  practice has ben abolished  ...

对，是个印度客户要的！这下就清楚点啦！谢谢啊！真的非常感谢！

xtdwwx

牛，居然是印度阿三的要求

懒虫9527

已阅，Mark

yangxiuq

Schedule M 是印度药品的GMP法规GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES,PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS
Shcedule M Part IF 是针对原料药进行的法规补充SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTIAL INGREDIENTS

不是印度企业怎么会有Shceduele M certificate呢，也许是想要原料药的GMP.

gmp-qc

论坛里果然是卧虎藏龙啊

smartzhenygx

yangxiuq 发表于 2016-9-21 10:22
Schedule M 是印度药品的GMP法规GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES,PLANT AND EQ ...

回复好专业啊！谢谢！