KudoZ question not available

Chinese translation: regulatory context FYI (medsafe certification?)

00:51 Sep 15, 2006
English to Chinese translations [PRO]
Bus/Financial - Manufacturing / certificate
English term or phrase: release for supply ...
Appears twice in the following context:

Title: Good Manufacturing Practice Certificate

XXX Company has been found to comply with the requirements for:

1. Manufacture and release for supply of bulk aspirin talbelts.

2. ...

Mr XXX is currently nominated as the person responsible for release for supply of bulk product manufacture on contract
English Chinese Medical Translator - Jimmy Deng
New Zealand
Local time: 19:36
Chinese translation:regulatory context FYI (medsafe certification?)
Explanation:
http://66.102.7.104/search?q=cache:UGxN9nCBBzEJ:www.honeynz....

--------------------------------------------------
Note added at 7 hrs (2006-09-15 07:53:29 GMT)
--------------------------------------------------

"Good Manufacturing Practice Certificate issued by Medsafe (New Zealand Medicines and Medical Devices Safety Authority).

Honey New Zealand hard/soft gelatin capsules and dry blend compressed tablets are produced in facilities certified to the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1: Manufacture of Pharmaceutical Products. The facilities comply with the requirements for:



manufacture, packing and release for supply of hard gelatin capsules and dry blend compressed tablets for apiary products;
manufacture, packing and release for supply of Aust R 68083;
packing and release for supply of soft gelatin capsules containing apiary products."


--------------------------------------------------
Note added at 7 hrs (2006-09-15 07:55:59 GMT)
--------------------------------------------------

search on 'manufacture, packing and release for supply'...'manufacturing practice for manufacture and distribution'...
'quality control for manufacture of therapeutic goods' ...

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:00:01 GMT)
--------------------------------------------------

therapeutic goods = 治疗产品:

[DOC] 导航File Format: Microsoft Word - View as HTML
With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for ... TGA, Therapeutic Goods Administration, (澳大利亚)治疗产品管理局. UK, United Kingdom, (大不列颠)联合王国 ...
www.zfda.gov.cn/back/affiche/attach/1062376691093.doc - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:09:16 GMT)
--------------------------------------------------

FYI GMP and 治疗产品:

理肤泉,医药科技背景的品牌 - [ Translate this page ]理肤泉温泉水疗中心 2001年11月6日,140余位上海的皮肤科医师与来自法国的皮肤科专家 共同参加了"皮肤科学的辅助性治疗暨La ... 而且,以理肤泉温泉水合成的理肤泉皮肤—美容 产品系列,是按照全面质量管理标准的(GMP)要求来生产的,其安全性及有效性均经过 ...
www.cn-cosmetic.com/6332.html - 15k - 13 Sep 2006 - Cached - Similar pages


深圳市赛百诺基因技术有限公司 - [ Translate this page ]作为中国第一家基因治疗专业公司,赛百诺创造了不凡的业绩。2003年10月,赛百诺公司 自主研制开发的基因治疗产品“重组人p53腺病毒注射液”(今又生,Gendicine)成功地取得 了国家食品药品监督管理局(SFDA)颁发的新药证书、生产批文和药品GMP证书,成为 ...
www.sibiono.com/cn/ - 10k - Cached - Similar pages


深圳市赛百诺基因技术有限公司 - [ Translate this page ]2003.10 重组人p53腺病毒注射液(今又生)获中国SFDA颁发的新药证书,标志着世界首个基因 治疗产品问世。 2004.01 重组人p53腺病毒注射液(今又生)获中国SFDA颁发的准生产批文。 2004.03 重组人p53腺病毒注射液(今又生)获中华人民共和国药品GMP证书及 ...
www.sibiono.com/cn/index.asp?CatalogID=50&ID=533&page=1 - 11k - Cached - Similar pages
[ More results from www.sibiono.com ]


科技型中小企业技术创新基金若干重点项目指南 - [ Translate this page ]... 批件外,还需要提供GMP证书;对于医药生产型企业的产业化项目,除应提供相关的新药 研究资料、批件外,还需要提供GMP证书,以及下一步生产的计划或合作生产的有关内容及 材料;本年度将治疗重大传染性疾病的药物、基因工程药物、中药现代化技术与产品列 ...
www.biotech.org.cn/news/news/show.php?id=33246 - 22k - 13 Sep 2006 - Cached - Similar pages



--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:25:24 GMT)
--------------------------------------------------

see 1.4 of this document (relating to veterinary medicines). there is also mention of authorised personnel:

http://66.102.7.104/search?q=cache:gKD9uyztywAJ:www.nzfsa.go...

好像 'release for supply' is a term in the context of quality control, the product must have been inspected and passed as being satisfactory for release by an authorised person before that person 'releases' it.

try also release from quarantine, for correct form of this word.

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:29:31 GMT)
--------------------------------------------------

release = 放行?:

小优优医药化工资源网 - 认证交流 - 一些英语词汇总结(页 1) - powered ... - [ Translate this page ]Repackaging重包装 Labeling 贴标 Relabeling 重贴标 regulatory inspections evaluation 药政检查 serious GMP deficiencies 严重GMP缺陷 release放行 review and approve 审核并批准 delegate 委派 distribution 销售 safety aspects 安全方面 ...
drugfocus.net/archiver/?tid-15508.html - 23k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:39:26 GMT)
--------------------------------------------------

新华制药(000756)_招股说明_公司资料_新浪财经 - [ Translate this page ]本公司生产的化学原料药包括解热镇痛药(主要为安乃近、阿司匹林、氨基比林、异丙安替 比林、布洛芬)、抗菌药(主要为吡哌酸、甲氧苄 ... 公司设技术质量保证部(QA )负责 生产过程质量控制和最终产品的放行,质检处负责进厂原料、最终产品的分析化验。 ...
finance.sina.com.cn/stock/company/sz/000756/7.shtml - 413k - Cached - Similar pages

'release for supply' seems to be the term used. but I have seen release for use, release for sale also...

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:43:23 GMT)
--------------------------------------------------

[PDF] EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE MASTER ...File Format: PDF/Adobe Acrobat - View as HTML
in the efficient planning and undertaking of a GMP inspection. ... Describe the system for the release for sale or supply of ...
www.newwayz.co.nz/refmaterial/pics_pe008_2SMF.pdf -


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:46:38 GMT)
--------------------------------------------------

-质量-SPC ,six sigma,TS16949,MSA,FMEA - 朋友交流2003年欧洲pIs诠释 ... - [ Translate this page ]vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in ... 与组织结构,文件制度,放行的流程有关, 质量控制将保证在产品被放行之前,产品已经被检查,检验并且被判定为符合要求。 ...
www.6sq.net/cdb/archiver/tid-29953.html - 8k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:49:47 GMT)
--------------------------------------------------

符合行銷要求的? 不可出貨? 不对了!

vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the marketing authorization;
7必須由授權人員認證產品是符合行銷要求的,否則任何產品不可出貨。

--------------------------------------------------
Note added at 8 hrs (2006-09-15 08:52:07 GMT)
--------------------------------------------------

出货 = dispatched/sent out - it is stock control, not quality control:

一路花开食色乱记| 11i各模块中文翻译 - [ Translate this page ]Supply Base 供货商基本数据库. Supplier 供货商. Supplier Merge 供货商合并. Supplier Statuses 供货商状态 ... Release Rule 捡货条件. Release Sequence Rules 库房出货顺序条件. RMA(Return Material Authorization) 退换货. Returns 退货 ...
lavendar.itpub.net/post/20762/156224 - 83k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 8 hrs (2006-09-15 08:58:46 GMT)
--------------------------------------------------

release for supply = release for supply of goods (here is information on the Australian regulations):

http://66.102.7.104/search?q=cache:cZJmUffokVMJ:www.tga.gov....

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:13:31 GMT)
--------------------------------------------------

放行为供应??

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:18:38 GMT)
--------------------------------------------------

合同默示条款三论/郑梁 - [ Translate this page ]之后,英国在货物买卖与服务提供领域又陆续制定了几部成文法,主要的有《1977年不公平 合同条款法》(Unfair Contract Terms Act 1977 )、《1979年货物销售法》(Sale of Goods Act 1979)《1982年货物和劳务供应法》(the Supply of Goods and Services ...
www.law-lib.com/lw/lw_view.asp?no=6858&page=2 - 19k - Cached - Similar pages

supply of goods 货物供应跟 sale of goods 货物销售比

IMO supply is being used in its legal 'sale of goods/consumer law/law of contract' sense.

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:20:29 GMT)
--------------------------------------------------

'release for supply' is the last stage of the manufacturing process - see the australian link.
Selected response from:

chica nueva
Local time: 19:36
Grading comment
thank you so much everyone. Lesley's references were particularly helpful
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +3投放市場
jyuan_us
4供货通知
yuzouren
3 +1批发放货
wherestip
3 +1regulatory context FYI (medsafe certification?)
chica nueva
4放發貨給供應商
pkchan


  

Answers


11 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
供货通知


Explanation:
已经可以供货,发布通知的意思


yuzouren
Japan
Local time: 16:36
Native speaker of: Native in ChineseChinese
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
批发放货


Explanation:
a suggestion

wherestip
United States
Local time: 02:36
Native speaker of: Native in EnglishEnglish, Native in ChineseChinese

Peer comments on this answer (and responses from the answerer)
agree  Ray Luo
16 hrs
  -> Thanks, Ray
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +3
投放市場


Explanation:
為了供貨而發出去-> 投放市場

jyuan_us
United States
Local time: 03:36
Native speaker of: Native in ChineseChinese
PRO pts in category: 12

Peer comments on this answer (and responses from the answerer)
agree  wherestip
1 hr

agree  chinesetrans
22 hrs

agree  pkchan
2 days 21 hrs
Login to enter a peer comment (or grade)

6 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
regulatory context FYI (medsafe certification?)


Explanation:
http://66.102.7.104/search?q=cache:UGxN9nCBBzEJ:www.honeynz....

--------------------------------------------------
Note added at 7 hrs (2006-09-15 07:53:29 GMT)
--------------------------------------------------

"Good Manufacturing Practice Certificate issued by Medsafe (New Zealand Medicines and Medical Devices Safety Authority).

Honey New Zealand hard/soft gelatin capsules and dry blend compressed tablets are produced in facilities certified to the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Part 1: Manufacture of Pharmaceutical Products. The facilities comply with the requirements for:



manufacture, packing and release for supply of hard gelatin capsules and dry blend compressed tablets for apiary products;
manufacture, packing and release for supply of Aust R 68083;
packing and release for supply of soft gelatin capsules containing apiary products."


--------------------------------------------------
Note added at 7 hrs (2006-09-15 07:55:59 GMT)
--------------------------------------------------

search on 'manufacture, packing and release for supply'...'manufacturing practice for manufacture and distribution'...
'quality control for manufacture of therapeutic goods' ...

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:00:01 GMT)
--------------------------------------------------

therapeutic goods = 治疗产品:

[DOC] 导航File Format: Microsoft Word - View as HTML
With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for ... TGA, Therapeutic Goods Administration, (澳大利亚)治疗产品管理局. UK, United Kingdom, (大不列颠)联合王国 ...
www.zfda.gov.cn/back/affiche/attach/1062376691093.doc - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:09:16 GMT)
--------------------------------------------------

FYI GMP and 治疗产品:

理肤泉,医药科技背景的品牌 - [ Translate this page ]理肤泉温泉水疗中心 2001年11月6日,140余位上海的皮肤科医师与来自法国的皮肤科专家 共同参加了"皮肤科学的辅助性治疗暨La ... 而且,以理肤泉温泉水合成的理肤泉皮肤—美容 产品系列,是按照全面质量管理标准的(GMP)要求来生产的,其安全性及有效性均经过 ...
www.cn-cosmetic.com/6332.html - 15k - 13 Sep 2006 - Cached - Similar pages


深圳市赛百诺基因技术有限公司 - [ Translate this page ]作为中国第一家基因治疗专业公司,赛百诺创造了不凡的业绩。2003年10月,赛百诺公司 自主研制开发的基因治疗产品“重组人p53腺病毒注射液”(今又生,Gendicine)成功地取得 了国家食品药品监督管理局(SFDA)颁发的新药证书、生产批文和药品GMP证书,成为 ...
www.sibiono.com/cn/ - 10k - Cached - Similar pages


深圳市赛百诺基因技术有限公司 - [ Translate this page ]2003.10 重组人p53腺病毒注射液(今又生)获中国SFDA颁发的新药证书,标志着世界首个基因 治疗产品问世。 2004.01 重组人p53腺病毒注射液(今又生)获中国SFDA颁发的准生产批文。 2004.03 重组人p53腺病毒注射液(今又生)获中华人民共和国药品GMP证书及 ...
www.sibiono.com/cn/index.asp?CatalogID=50&ID=533&page=1 - 11k - Cached - Similar pages
[ More results from www.sibiono.com ]


科技型中小企业技术创新基金若干重点项目指南 - [ Translate this page ]... 批件外,还需要提供GMP证书;对于医药生产型企业的产业化项目,除应提供相关的新药 研究资料、批件外,还需要提供GMP证书,以及下一步生产的计划或合作生产的有关内容及 材料;本年度将治疗重大传染性疾病的药物、基因工程药物、中药现代化技术与产品列 ...
www.biotech.org.cn/news/news/show.php?id=33246 - 22k - 13 Sep 2006 - Cached - Similar pages



--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:25:24 GMT)
--------------------------------------------------

see 1.4 of this document (relating to veterinary medicines). there is also mention of authorised personnel:

http://66.102.7.104/search?q=cache:gKD9uyztywAJ:www.nzfsa.go...

好像 'release for supply' is a term in the context of quality control, the product must have been inspected and passed as being satisfactory for release by an authorised person before that person 'releases' it.

try also release from quarantine, for correct form of this word.

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:29:31 GMT)
--------------------------------------------------

release = 放行?:

小优优医药化工资源网 - 认证交流 - 一些英语词汇总结(页 1) - powered ... - [ Translate this page ]Repackaging重包装 Labeling 贴标 Relabeling 重贴标 regulatory inspections evaluation 药政检查 serious GMP deficiencies 严重GMP缺陷 release放行 review and approve 审核并批准 delegate 委派 distribution 销售 safety aspects 安全方面 ...
drugfocus.net/archiver/?tid-15508.html - 23k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:39:26 GMT)
--------------------------------------------------

新华制药(000756)_招股说明_公司资料_新浪财经 - [ Translate this page ]本公司生产的化学原料药包括解热镇痛药(主要为安乃近、阿司匹林、氨基比林、异丙安替 比林、布洛芬)、抗菌药(主要为吡哌酸、甲氧苄 ... 公司设技术质量保证部(QA )负责 生产过程质量控制和最终产品的放行,质检处负责进厂原料、最终产品的分析化验。 ...
finance.sina.com.cn/stock/company/sz/000756/7.shtml - 413k - Cached - Similar pages

'release for supply' seems to be the term used. but I have seen release for use, release for sale also...

--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:43:23 GMT)
--------------------------------------------------

[PDF] EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE MASTER ...File Format: PDF/Adobe Acrobat - View as HTML
in the efficient planning and undertaking of a GMP inspection. ... Describe the system for the release for sale or supply of ...
www.newwayz.co.nz/refmaterial/pics_pe008_2SMF.pdf -


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:46:38 GMT)
--------------------------------------------------

-质量-SPC ,six sigma,TS16949,MSA,FMEA - 朋友交流2003年欧洲pIs诠释 ... - [ Translate this page ]vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in ... 与组织结构,文件制度,放行的流程有关, 质量控制将保证在产品被放行之前,产品已经被检查,检验并且被判定为符合要求。 ...
www.6sq.net/cdb/archiver/tid-29953.html - 8k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 7 hrs (2006-09-15 08:49:47 GMT)
--------------------------------------------------

符合行銷要求的? 不可出貨? 不对了!

vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the marketing authorization;
7必須由授權人員認證產品是符合行銷要求的,否則任何產品不可出貨。

--------------------------------------------------
Note added at 8 hrs (2006-09-15 08:52:07 GMT)
--------------------------------------------------

出货 = dispatched/sent out - it is stock control, not quality control:

一路花开食色乱记| 11i各模块中文翻译 - [ Translate this page ]Supply Base 供货商基本数据库. Supplier 供货商. Supplier Merge 供货商合并. Supplier Statuses 供货商状态 ... Release Rule 捡货条件. Release Sequence Rules 库房出货顺序条件. RMA(Return Material Authorization) 退换货. Returns 退货 ...
lavendar.itpub.net/post/20762/156224 - 83k - Supplemental Result - Cached - Similar pages


--------------------------------------------------
Note added at 8 hrs (2006-09-15 08:58:46 GMT)
--------------------------------------------------

release for supply = release for supply of goods (here is information on the Australian regulations):

http://66.102.7.104/search?q=cache:cZJmUffokVMJ:www.tga.gov....

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:13:31 GMT)
--------------------------------------------------

放行为供应??

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:18:38 GMT)
--------------------------------------------------

合同默示条款三论/郑梁 - [ Translate this page ]之后,英国在货物买卖与服务提供领域又陆续制定了几部成文法,主要的有《1977年不公平 合同条款法》(Unfair Contract Terms Act 1977 )、《1979年货物销售法》(Sale of Goods Act 1979)《1982年货物和劳务供应法》(the Supply of Goods and Services ...
www.law-lib.com/lw/lw_view.asp?no=6858&page=2 - 19k - Cached - Similar pages

supply of goods 货物供应跟 sale of goods 货物销售比

IMO supply is being used in its legal 'sale of goods/consumer law/law of contract' sense.

--------------------------------------------------
Note added at 8 hrs (2006-09-15 09:20:29 GMT)
--------------------------------------------------

'release for supply' is the last stage of the manufacturing process - see the australian link.

chica nueva
Local time: 19:36
Works in field
Native speaker of: English
PRO pts in category: 26
Grading comment
thank you so much everyone. Lesley's references were particularly helpful

Peer comments on this answer (and responses from the answerer)
agree  Danbing HE
6 days
Login to enter a peer comment (or grade)

12 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
放發貨給供應商


Explanation:
物流行業術語集錦- lucky - [ Translate this page ][ 簡體 ]Release cargo 放貨 Remaining on board (ROB) 船上所有 ... VENDOR MANAGED INVENTORY (VMI) 供應商管理庫存 ... ADVANCED SHIPPING NOTICE (ASN) 預先發貨通知 ...
blog.globalimporter.net/article_1383-18222.htm - 66k - Cached - Similar pages


pkchan
United States
Local time: 03:36
Native speaker of: Native in ChineseChinese
PRO pts in category: 4
Login to enter a peer comment (or grade)



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