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歐盟《制藥用水質(zhì)量指南》2020版（下）

5. Quality of Water for Pharmaceutical Use 制藥用水質(zhì)量

Validation andqualification of water purification, storage and distribution systems are afundamental part of GMP and form an integral part of the GMP inspection.

水純化、存貯和分配系統(tǒng)的驗(yàn)證和確認(rèn)是 GMP 的必要部分，是GMP 檢查中不可分割的一部分。

The grade of water usedat different stages in the manufacture of active substances and medicinalproducts should be discussed in the marketing authorisation application. Thegrade of water used should take account of the nature and intended use of thefinished product and the stage at which the water is used.

API和制劑生產(chǎn)的不同步驟所用水的級(jí)別應(yīng)在上市許可申報(bào)資料中進(jìn)行討論。所用水的級(jí)別選擇應(yīng)考慮制劑的特性和使用途徑，以及水被使用的步驟。

The following tables provide some general examples for guidance:

下表中給出了一些通用例子作為指導(dǎo)：

5.1. Water present as an excipient in the final formulation 作為最終制劑的輔料的水

Water is the mostcommonly used excipient in medicinal products: the minimum quality of waterselected depends on the intended use of the product, according to a risk basedapproach to be applied as part of an overall control strategy.

水是制劑中最常用的輔料：所選用水的最低質(zhì)量取決于藥品的用途，應(yīng)采用基于風(fēng)險(xiǎn)的方法，將其作為整體控制策略的一部分。

Table 1 summarises themain categories of sterile products. WFI is required for those productsintended for parenteral administration and this includes solutions forhaemofiltration and haemodiafiltration, peritoneal dialysis, irrigationsolution and biologics.

表1 中匯總了無菌藥品的主要類別。用于注射的藥品需要使用 WFI，其中包括血液濾過和血液透析、腹膜透析、沖洗液和生物制劑。

Sterile ophthalmic,nasal/ear and cutaneous preparations should be prepared using materials (water)designed to ensure sterility and to avoid the introduction of contaminants andthe growth of micro-organisms. According to the risk assessment, this couldrequire the use of water of higher quality than purified water.

無菌眼膏、鼻/耳劑和皮膚制劑應(yīng)使用能保證無菌性的原料（水）進(jìn)行生產(chǎn)，避免引入污染物，避免微生物繁殖。根據(jù)風(fēng)險(xiǎn)評(píng)估，這些可能要求使用比純化水質(zhì)量更高的水。

Table 1: Sterile Medicinal Products 表 1：無菌藥品

Table 2: Non-sterile Medicinal Products 表 2：非無菌制劑

*According to the outcomes of the riskassessment, WFI may be required in some cases for manufactureof non-sterile vaccines where in order toensure the vaccines’ safety and quality (avoiding introduction ofmicroorganisms undesirable in the specific finished product formulation)greater microbiological purity of water is needed.

根據(jù)風(fēng)險(xiǎn)評(píng)估結(jié)果，為確保疫苗的安全性和和高于純化水微生物純度的質(zhì)量（避免在特定制劑中引入不期望的微生物）有些非無菌疫苗的生產(chǎn)可能需要使用 WFI。

 

**In certain diseasestates (e.g. cystic fibrosis), medicinal products administered by nebulisationare required to be sterile and non-pyrogenic. In such cases, WFI should beused.

 在有些疾病狀態(tài)下（例如，囊性纖維化），需要通過無菌和無熱源霧化攝入藥品。這種情況下要使用 WFI。

 

***For some productssuch as veterinary teat dips, it may be acceptable to use potable water wherejustified and authorised taking account of the variability in chemicalcomposition and microbiological quality.

有些藥品如獸用乳頭浸蘸劑，可能可以使用飲用水，在論證和批準(zhǔn)時(shí)要考慮化學(xué)組成和微生物質(zhì)量的波動(dòng)。

 

5.2. Water used during manufacture of active substances and medicinalproducts excluding water present as an excipient in the final formulation 不作為最終制劑輔料的原料藥和制劑生產(chǎn)中所用水

 

The gradeof water will depend on the stage at which it is to be used during manufacture,the subsequent processing steps and the nature of the final product, accordingto a risk based approach to be applied as part of an overall control strategy.

 水的級(jí)別取決于其在生產(chǎn)中所用的步驟，后續(xù)的處理步驟，以及成品的特性。應(yīng)采用基于風(fēng)險(xiǎn)的方法，將其作為全面控制策略的一部分。

 

Table 3 summariseS the minimum acceptable quality of water for the manufacture of activesubstances.

 表3 中匯總了API 生產(chǎn)用水最低可接受質(zhì)量

 

Table 3: Water used during the manufacture ofActive Substances (AS)

表 3：活性物質(zhì)（AS）生產(chǎn)用水

* Purified Water should be used where there are technical requirementsfor greater chemical purity.

 

如果對(duì)化學(xué)純度有更高的技術(shù)要求，則應(yīng)使用純化水

 **  Refer to the monograph 2249 “Water forpreparation of extracts”.

參見 EP 專論 2249“提取用水”

 

***Appropriate specifications have to be set forendotoxins and microbiological quality of the active substance as per the relevantPh. Eur. chapters.

必須根據(jù)相關(guān)的 EP 章節(jié)為AS 制訂恰當(dāng)?shù)膬?nèi)毒素和微生物質(zhì)量標(biāo)準(zhǔn)

 

****Appropriate specifications have to be set formicrobiological quality of the active substance as per the relevant Ph. Eur.chapters.

必須根據(jù)相關(guān)的 EP 章節(jié)為AS 制訂恰當(dāng)?shù)奈⑸镔|(zhì)量標(biāo)準(zhǔn)

 

Table 4 summarises the acceptable quality ofwater for the manufacture of sterile and non-sterile medicinal products.

表 4 中匯總了無菌和非無菌藥品生產(chǎn)用水的可接受質(zhì)量

 

Table 4: Water used during manufacture ofmedicinal products but not present in the final formulation

表 4：不是最終制劑成分的制劑生產(chǎn)用水

* Purified Water should be used where there are technical requirementsfor greater chemical purity.

 

如果對(duì)化學(xué)純度有更高的技術(shù)要求，則應(yīng)使用純化水

 **  Refer to the monograph 2249 “Water forpreparation of extracts”.

參見 EP 專論 2249“提取用水”

 

***Appropriate specifications have to be set forendotoxins and microbiological quality of the active substance as per the relevantPh. Eur. chapters.

必須根據(jù)相關(guān)的 EP 章節(jié)為AS 制訂恰當(dāng)?shù)膬?nèi)毒素和微生物質(zhì)量標(biāo)準(zhǔn)

 

****Appropriate specifications have to be set formicrobiological quality of the active substance as per the relevant Ph. Eur.chapters.

必須根據(jù)相關(guān)的 EP 章節(jié)為AS 制訂恰當(dāng)?shù)奈⑸镔|(zhì)量標(biāo)準(zhǔn)

 

Table 4 summarises the acceptable quality ofwater for the manufacture of sterile and non-sterile medicinal products.

表 4 中匯總了無菌和非無菌藥品生產(chǎn)用水的可接受質(zhì)量

 

Table 4: Water used during manufacture ofmedicinal products but not present in the final formulation

表 4：不是最終制劑成分的制劑生產(chǎn)用水

*  CIP = Clean In Place 原位清潔

 

**Some containers, e.g. plastic containers foreyedrops may not need an initial rinse, indeed this may be counter-productivesince particulates counts could be increased as a result. In some cases e.g.blow-fill-seal processes rinsing cannot be applied.

有些容器如滴眼劑所用塑料容器可能不需要初次淋洗，實(shí)際上可能適得其反，因?yàn)檫@樣可能會(huì)增加微粒數(shù)量。在某些情況下如吹灌封工藝中，是無法沖洗的。

 

*** For injection for veterinary use, PurifiedWater may be used for cleaning/rinsing of equipment, containers, closures, ifthe preparation falls into the exempted category from test for bacterialendotoxins (2.6.14) or test for pyrogens (2.6.8) by the Ph. Eur. monograph “Parenteralpreparations” (0520). In this case, a risk based approach to justify the use ofpurified water instead of WFI must be implemented as part of an overall controlstrategy and particularly to ensure sterility and to avoid the introduction ofcontaminants and the growth of micro-organisms in the final product.

對(duì)于獸用注射劑，設(shè)備、容器、密閉器清潔/淋洗可使用純化水，如果根據(jù) EP 專論“注射劑（0520）”，該制劑可免于檢測(cè)細(xì)菌內(nèi)毒素（2.6.14）和熱原（2.6.8）。在此情況下，必須基于風(fēng)險(xiǎn)對(duì)使用純化水而不是 WFI 的做法進(jìn)行論證，將其作為全面控制策略的一部分，尤其要確保無菌性，避免引入污染物，避免制劑中微生物的滋生。