【正文】 e necessity of intermediate or pharmaceutical input recallr) 批準(zhǔn)校驗(yàn)和預(yù)防性維修計(jì)劃，并證明已經(jīng)正確地執(zhí)行approve the calibration and preventive maintenance program and certify its correct execution. 質(zhì)量控制的責(zé)任Responsibilities of the Quality Control。 (n) 進(jìn)行產(chǎn)品質(zhì)量評審perform reviews of product quality。certify that stability studies are conducted。certify that there is an effective maintenance and calibration system of equipments。certify that plaints and returns related to the quality should be recorded, investigated and, when necessary, corrective actions are implemented。approve master plan, protocol and reports of validation and assure that necessary validations are carried out。approve changes affecting and that potentially may affect the quality of intermediate and pharmaceutical input。approve technical specifications, third party service contracting related to manufacturing and Quality Control of intermediates and active pharmaceutical input。approve the Selfinspection Program and certify that it is executed。approve all procedures, specifications and instructions that cause impact on the quality of the intermediate or pharmaceutical input。certify that quality deviations are investigated and corrective actions are implemented。review documentation of production record and Quality Control of the manufactured lot, before its release for expedition。establish and monitor a system for releasing or rejecting raw materials, intermediates, packaging and labeling materials used during manufacturing。這些責(zé)任應(yīng)該在文件中規(guī)定，至少涉及下列活動：The main responsibilities of the Quality Unit should not be delegated. These responsibilities should be defined and documents contemplating at least the following activities:a) 放行和否決所有的中間品和藥物活性成分release or reject all intermediates or active pharmaceutical inputs。inspection and investigation of factors that may affect the quality of intermediate and pharmaceutical input. 質(zhì)量部門的責(zé)任Responsibilities of the Quality Unit。j) 監(jiān)督是否符合然GMP monitoring of pliance with the GMP。h) 規(guī)定物料和產(chǎn)品的存儲條件specifications of storage conditions of materials and products。f) 供應(yīng)商資格確認(rèn) supplier qualification。d) 工藝驗(yàn)證 validation of the process。b) 監(jiān)督和控制生產(chǎn)環(huán)境 monitoring and control of manufacturing environment。The responsible persons for Production, quality control and quality unit of intermediates and active pharmaceutical inputs should be entitled according to the actual legislation of the respective representative class board and qualified with proper education, experience and/or training.：The responsible persons for Production and quality unit should exert together certain activities related to quality, such as:a) 程序和文件的制定和復(fù)核包括對其進(jìn)行更新。The main posts of Production and Quality Unit should be occupied by personnel working full time at the firm. There may be necessary to delegate some functions, however, responsibility can39。There must be procedures to notify the Quality Unit whenever quality deviations occur, including related actions. 職責(zé)Responsibilities 介紹Introduction。但中間品和藥物活性成分沒有例外。All deviations should be documented and explained. Critical deviations should be investigated, and this investigation and its conclusions should be documented 在質(zhì)量部門對于物料質(zhì)量作出滿意的結(jié)論之前，不得放行和使用這些物料。All activities related to quality should be recorded after their performance. 所有的偏差應(yīng)該由文件證明和說明。There must be an independent Quality Unit of production, which prises responsibilities of both Quality Assurance (QA) and Quality Control (QC), that pletes the production responsibilities. The Quality Unit can be represented by a single person or by a group or department, depending on the size and structure of the organization. 授權(quán)放行中間品和藥物活性成分的人員應(yīng)該確定好。There must be a quality unit responsible for assuring that intermediates and active pharmaceutical inputs are within the demanded quality standards and that can be used for the proposed purposes. 質(zhì)量部門必須獨(dú)立于生產(chǎn)部門，其職能包括質(zhì)量保證和質(zhì)量控制。所有相關(guān)的活動都應(yīng)該在文件中規(guī)定。s collaborators. 生產(chǎn)廠家應(yīng)該建立執(zhí)行和保持有效的文件化的質(zhì)量管理體系，并使管理層和所有與生產(chǎn)有關(guān)的人員積極參與。quality Management is the aspect of management function that determines and implements the “Quality Policy”, ., the overall intentions and directions related to quality, formally expressed and authorized by the firm high management. 原則Principles 公司的所有人員對質(zhì)量負(fù)有責(zé)任。 生物制品應(yīng)從工作種子庫的維護(hù)工序就開始要求GMP管理。 生產(chǎn)企業(yè)對產(chǎn)品質(zhì)量負(fù)責(zé)。 生產(chǎn)企業(yè)應(yīng)保證產(chǎn)品符合既定質(zhì)量。（第九章至第十七章）第一章 一般考慮 企業(yè)資質(zhì)文件齊全，經(jīng)常受到藥監(jiān)部門的檢查。 第二部分：對影響產(chǎn)品質(zhì)量的6要素（5M1E）提出具體要求；對貫穿于所有方面的文件管理提出具體要求。 巴西GMP基本框架 第一部分：說明GMP是質(zhì)量管理體系的一種；指明質(zhì)量管理的基本原則與職責(zé)。巴西GMP沿用了Q7A的基本原則與框架，大致內(nèi)容也與其相同，但是，巴西GMP也融入了巴西衛(wèi)生部對GMP的理解與要求，使之比Q7A更具體、更嚴(yán)格。ICH（人用藥品注冊技術(shù)要求國際協(xié)調(diào)會議）由三個地區(qū)的代表組成，即歐盟、美國和日本。巴西衛(wèi)生部原料藥與中間品 GMP巴西 GMP簡介 巴西GMP是在Q7A的基礎(chǔ)上建立起來的。 Q7A是ICH對原料藥生產(chǎn)的指導(dǎo)性文件。ICH指導(dǎo)文件是三方公認(rèn)的國際標(biāo)準(zhǔn)，同時ICH指導(dǎo)文件也日益成為國際上公認(rèn)的藥品注冊技術(shù)標(biāo)準(zhǔn)。 巴西GMP與中國GMP的比較 中國沒有單獨(dú)針對原料藥生產(chǎn)的GMP要求，現(xiàn)行98年修訂版 GMP，內(nèi)容過于簡單，版本過于陳舊，兩者差距非常大，不可同日而語。（第一章至第二章）。（第三章至第八章）第三部分：對藥品生產(chǎn)質(zhì)量管理的其它幾個重要方面提出具體要求。 （要準(zhǔn)備：藥監(jiān)部門的檢查記錄與報告） 原料藥生產(chǎn)應(yīng)遵循該法規(guī)。 質(zhì)量保證、質(zhì)量控制、GMP是密切相關(guān)的三個概念。 要有齊全的證據(jù)標(biāo)明：企業(yè)在影響產(chǎn)品質(zhì)量的各個方面實(shí)行了GMP管理。2. 質(zhì)量管理QUALITY MANAGEMENT質(zhì)量管理決定和執(zhí)行公司的質(zhì)量方針,即與質(zhì)量有關(guān)的總體方向和目標(biāo),其管理職能由公司的高級管理層正式宣布并授權(quán)。The quality should be responsibility of all the pany39。Each manufacturer should establish, document, implement and keep an effective system of quality management, which involves active participation of the management and all personnel involved in manufacturing. 質(zhì)量管理體系包括公司的組織結(jié)構(gòu)、程序、過程、資源和必要的活動,確保中間品和藥物活性成分符合規(guī)定的質(zhì)量和純度要求。The system for quality management should prise the organizational structure, procedures, processes, resources and necessary activities to assure that the intermediate and the pharmaceutical input are in conformity with the intended specifications of quality and purity. All related activities should be defined and documented. 必須有一個質(zhì)量部門負(fù)責(zé)保證中間品和藥物活性成分滿足規(guī)定的質(zhì)量標(biāo)準(zhǔn)，并達(dá)到使用要求。質(zhì)量部門可以有一個人或一個小組和部門組成，這取決于公司的大小和結(jié)構(gòu)。The employees authorized to release intermediates and active pharmaceutical inputs should be defined. 所有與質(zhì)量相關(guān)的活動在完成后應(yīng)予記錄。對關(guān)鍵偏差應(yīng)進(jìn)行調(diào)查，調(diào)查過程和調(diào)查結(jié)論應(yīng)該