道地藥材產(chǎn)品認(rèn)證規(guī)范

1、RBT1道地藥材產(chǎn)品認(rèn)證規(guī)范Specificationfcertificationofgeoauthenticcrudedrugproduct(征求意見稿)RB中華人民共和國認(rèn)證認(rèn)可行業(yè)標(biāo)準(zhǔn)中華人民共和國認(rèn)證認(rèn)可行業(yè)標(biāo)準(zhǔn)RBXXXX—XXXXICS03.120.20C32備案號(hào)：XXXXXXXX發(fā)布國家認(rèn)證認(rèn)可監(jiān)督管理委員會(huì)發(fā)布實(shí)施RBTXXXXXXXXI目次前言.....................................

2、......................................................................................................II引言..................................................................................................................

3、........................III1范圍.............................................................................................................................................12規(guī)范性引用文件........................................

4、.................................................................................13術(shù)語和定義.................................................................................................................................14道

5、地沿革基本要求.....................................................................................................................34.1道地產(chǎn)區(qū)........................................................................................

6、.................................44.2藥材基原.........................................................................................................................44.3特定生產(chǎn)加工方法..............................................

7、...........................................................44.4性狀特征.........................................................................................................................44.5臨床療效........................

8、.................................................................................................45藥材生產(chǎn)基本要求.................................................................................................................

9、....45.1產(chǎn)區(qū)選址和環(huán)境基本要求.............................................................................................45.2種子種苗及動(dòng)物種源...............................................................................................

10、......55.3種植、養(yǎng)殖管理.............................................................................................................55.4采收及產(chǎn)地加工...................................................................................

11、..........................66道地藥材飲片生產(chǎn).....................................................................................................................77產(chǎn)品質(zhì)量.............................................................

12、........................................................................78包裝、運(yùn)輸和貯藏.....................................................................................................................78.1包裝...............

13、..................................................................................................................78.2運(yùn)輸....................................................................................................

14、.............................88.3貯藏.................................................................................................................................89管理....................................................

15、.........................................................................................89.1文件管理.........................................................................................................................89

16、.2機(jī)構(gòu)和人員.....................................................................................................................89.3產(chǎn)品追溯........................................................................................

17、.................................99.4投訴與召回.....................................................................................................................99.5持續(xù)改進(jìn).....................................................

18、....................................................................910道地藥材產(chǎn)品認(rèn)證名稱及標(biāo)志使用與管理.............................................................................9附錄A（規(guī)范性附錄）道地藥材產(chǎn)品認(rèn)證品種名錄...............................