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Guidelineon the quality of water for pharmaceutical use

制藥用水質(zhì)量指南

This guideline replaces the Note for guidanceon quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01)and CPMP Position Statement on the Quality of Water used in the production ofVaccines for parenteral use (EMEA/CPMP/BWP/1571/02 Rev.1).

本指南取代“制藥用水質(zhì)量指南說明”（CPMP/QWP/158/01 EMEA/CVMP/115/01）和CPMP《注射疫苗生產(chǎn)用水質(zhì)量立場聲明》（EMEA/CPMP/BWP/1571/02 rev.1）。

一Executive summary 執(zhí)行摘要

This guideline replaces the Note for Guidanceon quality of water for pharmaceutical use (CPMP/QWP/158/01, EMEA/CVMP/115/01)originally adopted in May 2002, and the CPMP Position Statement on the Qualityof Water used in the production of Vaccines for parenteral use(EMEA/CPMP/BWP/1571/02 rev.1).

本指南取代 2002 年 5 月生效的《制藥用水質(zhì)量指南說明》

（CPMP/QWP/158/01, EMEA/CVMP/115/01），和CPMP《注射疫苗生產(chǎn)用水質(zhì)量立場聲明》（EMEA/CPMP/BWP/1571/02 rev.1）。

The note for guidance has been updated to reflect the followingchanges in the European Pharmacopoeia:

此次對指南說明進(jìn)行了更新，反映出歐洲藥典中的以下變化：

revised monograph for Water for Injections(0169) allowing the possibility to use methods other than distillation forproducing water of injectable quality;

注射用水（0619）專論修訂內(nèi)容，修訂后允許使用非蒸餾方法制備注射用水；

new monograph for Water for preparation of extracts (2249);

新訂提取用水專論（2249）；

suppression of the monograph for Water, highly purified (1927).

廢除高純水專論（1927）

The guideline has alsobeen updated to reflect current expectations for the minimum acceptable qualityof water used in the manufacture of active substances and medicinal productsfor human and veterinary use.

本指南亦進(jìn)行了更新，以反映目前對人用與獸用 API 和制劑生產(chǎn)用水的最低可接受質(zhì)量標(biāo)準(zhǔn)要求。

1、Introduction (background) 概述（背景）

Water is one of themajor utilities used by the pharmaceutical industry. It may be present as anexcipient or used for reconstitution of products, during synthesis, duringproduction of the finished product or as a cleaning agent for rinsing vessels,equipment, primary packaging materials, etc.

水是制藥行業(yè)所用的主要公用系統(tǒng)之一。它可以作為輔料使用，亦可用于藥品調(diào)配；可用于合成，亦可用于制劑生產(chǎn)，或作為清潔劑用于淋洗貯罐、設(shè)備、內(nèi)包材等。

Different grades of water quality are requireddepending on the different pharmaceutical uses. Control of the quality ofwater, in particular the microbiological quality, is a major concern and thepharmaceutical industry devotes considerable resource to the development andmaintenance of water purification systems.

不同級別的水質(zhì)量由藥品的不同用途決定。水質(zhì)檢測，尤其是微生物質(zhì)量，是重要的關(guān)注點(diǎn)，制藥企業(yè)都會投入相當(dāng)大的資源建設(shè)和維護(hù)制水系統(tǒng)。

The European Pharmacopoeia (Ph. Eur.) providesquality standards for grades of water for pharmaceutical use including Waterfor Injections (WFI), Purified Water and Water for preparation of extracts.

歐洲藥典提供了不同級別制藥用水的質(zhì)量標(biāo)準(zhǔn)，包括注射水（WFI）、純化水和提取用水。

Until April 2017, the production of Water forInjections (WFI) had been limited to production by distillation only. Followingextensive consultation with stakeholders, the Ph. Eur. monograph for Water forInjections (0169) was revised in order to allow the production of WFI by apurification process equivalent to distillation, such as reverse osmosis, whichmay be single-pass or double-pass, coupled with other appropriate techniquessuch as electro-deionisation, ultrafiltration or nanofiltration. The revisedmonograph was published in the Ph. Eur. Supplement 9.1 and became effective on1 April 2017.

2017 年 4 月前，注射水的制備僅限于使用蒸餾方法。在廣泛征求利益相關(guān)人意見之后，EP 修訂了注射用水專論（0169），允許采用等同于蒸餾的純化工藝制備 WFI，例如反滲透方法，可以是單通道，亦可以是雙通道，配以其它適當(dāng)?shù)募夹g(shù)如電除鹽、超濾或納濾。修訂后的專論已在 EP9.1 中發(fā)布，于 2017 年 4 月 1 日生效。

This change brings thePh. Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia, allowing production of WFI by distillation or by a purificationprocess proven “equivalent or superior to distillation”, and “by distillationor by reverse osmosis and/or ultrafiltration”, respectively.

該變化使用EP 與 USP 和 JP 更為接近，后 2 者分別允許使用蒸餾和其它被證明“等同或優(yōu)于蒸餾的”純化工藝，“通過蒸餾或反滲透和/或超濾”制備 WFI。

In addition, the Ph.Eur. Commission has adopted a new policy for the test for bacterial endotoxins,reflected in the revision of general chapter 5.1.10 Guidelines for using thetest for bacterial endotoxins and the general monograph for Substances forpharmaceutical use (2034). As a consequence, new monographs forsubstances for pharmaceutical use will no longer include the test for bacterialendotoxins (with possible exceptions). This aspect is now covered by thegeneral monograph, which includes recommendations for establishing limits andinformation on how to evaluate the pyrogenicity of substances and where,according to the monographs on Parenteral preparations (0520) and Preparationsfor irrigation (1116), the requirements apply to the finished product.

此外，EP 委員會已通過了新的細(xì)菌內(nèi)毒素檢查方針，反映在通則 5.1.10“細(xì)菌內(nèi)毒素檢測使用指南”和“藥用物質(zhì)（2034）”通論的修訂版本中。這樣，新的藥用物質(zhì)通論將不再包括細(xì)菌內(nèi)毒素檢測（可能有例外）。目前該內(nèi)容由通論覆蓋，其中包括了建立限度的建議和如何評估藥用物質(zhì)熱原性的信息。根據(jù)注射劑（0520）專論和灌注劑（1116）專論，上述這些要求均適用于制劑。

Theopportunity has also been taken to update terminology and requirements toreflect current expectations.

同時我們還借此機(jī)會更新了術(shù)語和要求，以反映出目前的期望。

2、Scope 范圍

This document isintended to provide guidance to the industry on the pharmaceutical use ofdifferent grades of water in the manufacture of active substances and medicinalproducts for human and veterinary use and should be considered for newmarketing authorisation applications, as well as any relevant variationapplication to existing marketing authorisations.

本文件旨在為制藥企業(yè)提供人用和獸用 API 和制劑生產(chǎn)中所用的不同級別制藥用水的指南。新的上市許可申報(bào)，以及對現(xiàn)有 MA 的任何相關(guān)變更申報(bào)均應(yīng)考慮本指南。

This guidance alsoapplies to Advanced Therapy Medicinal Products (ATMPs). Where applicable,guidance is provided to include preparation of critical starting materials suchas viral vectors and on cell based medicinal products where terminalsterilisation is not possible. For additional specific guidance for AdvancedTherapy Medicinal Products, applicants and manufacturers are advised to consultthe EC guidelines on Good Manufacturing Practice (GMP) specific to AdvancedTherapy Medicinal Products (ATMPs).

本指南亦適用于先進(jìn)治療藥品（ATMP）。在適用時，指南包括有關(guān)鍵起始物料的制備，如病毒載體和無法進(jìn)行最終滅菌的基于細(xì)胞的藥品。關(guān)于 ATMP 的其它專用指南，建議申報(bào)人和生產(chǎn)者查詢 EC 的 ATMP GMP 指南。

Where relevant, the principles of this guideline may also be appliedto investigational medicinal products.

本指南亦可用于臨床試驗(yàn)用藥品（如相關(guān)）。

This guidance is notintended to cover the water used in situations where medicinal products areprepared extemporaneously or where preparations are reconstituted/diluted withwater prior to use by a pharmacist/user (e.g. water for reconstituting oralantibiotic mixtures, water for diluting haemodialysis solutions) or in the caseof veterinary products, by the user (e.g. powder for use in drinking water).

本指南不包括臨時制備藥品或藥師/使用者在使用之前重新調(diào)配/稀釋制劑的情況（例如，重新調(diào)配口服抗菌混合物所用的水，稀釋血液透析溶液所用水），以及用戶配制獸藥時所用水（例如，用于飲用水的粉末）。

This guidelinecomplements the “Questions and answers on production of water for injections bynon-distillation methods – reverse osmosis and biofilms and control strategiesEMA/INS/GMP/443117/2017 GMP/GDP Inspectors Working Group” which has beenpublished following the implementation of the revised monograph for Water forInjections (0169) and it is intended that the guideline and Q&A should beread together.

本指南補(bǔ)充在注射用水（0169）修訂之后為其實(shí)施所發(fā)布的“非蒸餾方法（反滲透和生物膜）制備注射用水和控制策略問答 MA/INS/GMP/443117/2017 GMP/GDP 檢查工作組”。本指南應(yīng)與該問答指南一起解讀。

3、 Legal basis 法規(guī)依據(jù)

Thisguideline has to be read in conjunction with the introduction and generalprinciples sections 4 & 5 of Annex I to Directive 2001/83/EC and theintroduction and general principles section 2 & 3 of Annex I to Directive2001/82/EC.

本指南應(yīng)與歐盟指令 2001/83/EC 附錄 1 第 4&5 節(jié)概述和通則，以及指令 2001/82/EC 附錄 1 的第 2&3 節(jié)通則一起解讀。

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