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4. Requirements of the European Pharmacopoeia 歐洲藥典的要求

The European Pharmacopoeia provides quality standards for thefollowing grades of water:

歐洲藥典為以下級(jí)別的水設(shè)置了質(zhì)量標(biāo)準(zhǔn)：

·        Water for Injections

·        注射用水

·        Purified Water

·        純化水

·        Water for preparation of extracts

·        提取用水

4.1. Potable Water 飲用水

Potable Water is notcovered by a pharmacopoeial monograph but must comply with the regulations on waterintended for human consumption of a quality equivalent to that defined inDirective 98/83/EC or laid down by the competent authority. Testing should becarried out by the manufacturer to confirm the quality of the water. Potablewater may be used during the manufacture of active substances and in the earlystages of cleaning pharmaceutical manufacturing equipment unless there arespecific technical or quality requirements for higher grades of water. It isthe prescribed source feed water for the production of pharmacopoeial gradewaters.

飲用水沒有藥典專論，但必須符合歐盟指令 98/83/EC 中規(guī)定的人用飲用水質(zhì)量要求，或各成員國相關(guān)機(jī)構(gòu)規(guī)定的標(biāo)準(zhǔn)。生產(chǎn)商應(yīng)進(jìn)行檢測，以確認(rèn)水質(zhì)。飲用水可用于 API 和平，可用于清潔較前工藝用藥品生產(chǎn)設(shè)備，有特定技術(shù)或要求使用更高質(zhì)量水者除外。它是指定用于制備制藥用水的源水。

4.2. Water for Injections (WFI)注射用水（WFI）

Water for Injections(WFI) is water for the preparation of medicines for parenteral administrationwhen water is used as a vehicle (water for injections in bulk) and fordissolving or diluting substances or preparations for parenteral administration(sterilised water for injections).

WFI是注射用藥品制備用水，這時(shí)水是載體（散裝注射水），用于溶解或稀釋藥用物質(zhì)或制備注射給藥的制劑（滅菌的注射水）。

For a detaileddescription of the production and control of Water for Injections refer to Ph.Eur. monograph 0169. It should be noted that when reverse osmosis is to beintroduced at the local manufacturing site, notice should be given to the GMPsupervisory authority of the manufacturer before implementation as described inthe Compilation of Community Procedureson Inspections and Exchange ofInformation.

注射用水的制備和檢測詳細(xì)信息參見 EP 專論 0169。應(yīng)注意如果在生產(chǎn)工廠本地使用了反滲透制備方法，則應(yīng)按“歐盟檢查和信息交換程序匯編”所述在實(shí)施之前向生產(chǎn)商的GMP監(jiān)管機(jī)構(gòu)提交通知。

4.3. Purified Water 純化水

Purified Water is waterfor the preparation of medicines other than those that are required to be bothsterile and apyrogenic, unless otherwise justified and authorised.

純化水是不需要無菌或除熱原的藥品制備用水，另有論證和批準(zhǔn)者除外。

Purified Water whichsatisfies the test for endotoxins described in Ph. Eur. monograph 0008 may beused in the manufacture of dialysis solutions.

符合 EP 專論 0008 中所述內(nèi)毒素檢測要求的純化水可用于透析液的生產(chǎn)。

For a detaileddescription of the production and control of Purified Water refer to Ph. Eur.monograph 0008.

純化水的制備和檢測詳細(xì)信息參見 EP 專論 0008。

4.4. Water for preparation of extracts 提取用水

Water for preparationof extracts is water intended for the preparation of Herbal drug extracts(0765) which complies with the sections Purified water in bulk or Purifiedwater in containers in the monograph Purified water (0008), or is waterintended for human consumption of a quality equivalent to that defined inDirective 98/83/EC which is monitored according to the Production sectiondescribed in the monograph.

提取用水是草藥提取物（0765）生產(chǎn)用水，應(yīng)符合純化水專論（0008）中散裝純化水或容器中的純化水章節(jié)的要求，或指令 98/83/EC 中規(guī)定的人用水質(zhì)要求。該水應(yīng)根據(jù)專論中生產(chǎn)章節(jié)進(jìn)行監(jiān)測。

For a detailed description of the production and control of Water forpreparation of extracts refer to Ph.
Eur. Monograph 2249.

提取用水的制備和檢測詳細(xì)信息參見 EP 專論 2249。