1、Sterile devices are never exempted from GMP requirements.
消毒器械從不受GMP要求豁免。

2、Is the QC laboratory of your company well-organized according to the GMP Guidelines ?
您公司質(zhì)控實驗室工作是按照藥品GMP(2010年修訂)要求妥善組織的嗎？

3、Test the platelet GMP -140 on the Flow Cytometer after 2 hours and within 24 hours.
待2小時后、24小時內(nèi)在流式細胞儀上檢測血小板GMP一140水平。

4、Understanding knowledge about GMP and having the knowledge about the production management.
了解GMP方面的知識和具備精益生產(chǎn)管理相關(guān)經(jīng)驗。

5、The company has obtained the GMP certification from SDA in July, 2000.
公司于2000年7月通過了國家藥品監(jiān)督局的GMP認證。

6、OBJECTIVE: To provide reference for meeting with GMP requirement in hospital preparations.
目的：為醫(yī)院制劑達到GMP要求提供參考建議。

7、The optimum structure is adopted according to GMP requirements.
該機采用了適合GMP要求的優(yōu)化結(jié)構(gòu)。

8、WB_(852) showed no effect on cAMP andc GMP levels in EAC cells.
WB_(852)腹腔連續(xù)用藥7天對EAC細胞內(nèi)cAMP和cGMP含量均無明顯影響。

9、Be responsible for quality deviation and GMP corrective action.
負責質(zhì)量偏差和GMP糾正行動。

10、The designation of a device as a "custom" or "customized" device does not confer a GMP exemption.
以定制或定制化所指定的器械并不授予GMP豁免。

11、Participate in internal GMP inspection for all manufacturing functions.
參與所有生產(chǎn)操作的GMP內(nèi)審。

12、Do you have a deviation investigation procedure following requirements of the GMP Guidelines ?
您是按照藥品GMP(2010年修訂)要求制定的偏差調(diào)查程序嗎？

13、Manufacturers should be aware of the GMP exemption status of their devices.
制造商應(yīng)知曉其產(chǎn)品的GMP豁免狀態(tài)。

14、All numbering within this section coincides with actual numbering in the GMP Provision.
本節(jié)中的所有編號與GMP規(guī)定的實際編號一致。

15、These contract laboratories are not subject to routine GMP inspections.
這些合同式實驗室不必接受GMP的例行檢查。

16、Do you have an OOS investigation procedure, which follows the requirements of the GMP Guidelines ?
您是按照藥品GMP(2010年修訂)要求制定的超標檢驗數(shù)據(jù)調(diào)查程序嗎？

17、Do you establish a well-organized GMP documentation system?
您是否建立了清晰明確的藥品GMP文件體系？

18、Do you perform a validation for water system properly according to GMP Guidelines ?
您按照藥品GMP(2010年修訂)的要求對水系統(tǒng)進行適當確認了嗎？

19、Process validation is a key in execution of GMP in pharmaceutical enterprise.
工藝驗證是制藥企業(yè)實施GMP規(guī)范的關(guān)鍵問題。

GMP翻譯