過(guò)程確認(rèn)及方法概述PPT

1、123456789101112131415Installation qualification (IQ)安裝鑒定（IQ） Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturers approved specification and that the recommendations of the supplier of the equipment are suitabl

2、y considered.用客觀(guān)證據(jù)來(lái)支持證明，所安裝的過(guò)程設(shè)備和輔助系統(tǒng)的關(guān)鍵安裝方面，能滿(mǎn)足制造商已批準(zhǔn)的技術(shù)規(guī)范，且供應(yīng)商的建議也被恰當(dāng)?shù)目紤]了。16Operational qualification (OQ)操作鑒定（OQ）Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements 用客觀(guān)證據(jù)確定能夠生產(chǎn)出滿(mǎn)足所有預(yù)定要求的產(chǎn)品的過(guò)程控制極限和行動(dòng)標(biāo)準(zhǔn)。 17Per

3、formance qualification (PQ)性能鑒定（PQ）establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.用客觀(guān)證據(jù)確定，在預(yù)期條件下，過(guò)程能連續(xù)地產(chǎn)出符合所有預(yù)定要求的產(chǎn)品。 181920212223過(guò)程確認(rèn)的要素過(guò)程確認(rèn)的要素確認(rèn)確認(rèn)安裝鑒定安裝鑒定操作鑒定操作鑒定性能鑒定性能鑒定開(kāi)發(fā)開(kāi)發(fā)24何時(shí)確認(rèn)何時(shí)確認(rèn)A過(guò)程

4、輸出可驗(yàn)證嗎？B驗(yàn)證是充分及成本可接受嗎？C驗(yàn)證并控制過(guò)程D確認(rèn)E重新設(shè)計(jì)產(chǎn)品和/或過(guò)程252627282930313233343536Protocol development方案編制 Process validation protocols should include the following elements:過(guò)程確認(rèn)方案應(yīng)該包括如下元素：l Complete description of the process 過(guò)程的完整描述 l Identification of the process to be validated 要確認(rèn)的過(guò)程標(biāo)識(shí) l Select the worst cas

5、e 選擇最差條件（產(chǎn)品）l Identification of device(s) to be manufactured using this process 在這個(gè)過(guò)程下產(chǎn)出的器械的標(biāo)識(shí) l Objective and measurable criteria for a successful validation 一個(gè)成功確認(rèn)的目標(biāo)和可測(cè)量的標(biāo)準(zhǔn) l Length and duration of the validation 確認(rèn)的用時(shí)和有效期限 l Shifts, operators, equipment to be used in the process 過(guò)程中采用的輪班制、操作人員和設(shè)

6、備l Identification of utilities for the process equipment and quality of the utilities 過(guò)程設(shè)備中使用器具(utilities)的標(biāo)識(shí)和質(zhì)量l Identification of operators and required operator qualification 操作員識(shí)別和要求的操作員資格（證） l 37Protocol development方案編制 、l Relevant specifications that relate to the product, components, manufact

7、uring materials, etc 產(chǎn)品、元件、生產(chǎn)材料等的相關(guān)規(guī)格 l Any special controls or conditions to be placed on preceding processes during the validation 在（過(guò)程）確認(rèn)中，對(duì)先發(fā)生的過(guò)程所設(shè)置的任何特殊控制或條件 l Process parameters to be monitored, and methods for controlling and monitoring 要監(jiān)控的過(guò)程參數(shù)和監(jiān)控方法 l Product characteristics to be monitored

8、and method for monitoring 監(jiān)視的產(chǎn)品特性和方法 l Any subjective criteria used to evaluate the product 用來(lái)評(píng)估產(chǎn)品的主觀(guān)標(biāo)準(zhǔn) l Definition of what constitutes non-conformance for both measurable and subjective criteria 對(duì)于可測(cè)量標(biāo)準(zhǔn)和主觀(guān)標(biāo)準(zhǔn)，定義什么是不合格 l Statistical methods for data collection and analysis 數(shù)據(jù)收集和分析的統(tǒng)計(jì)方法 l Considerati

9、on of maintenance and repairs of manufacturing equipment 生產(chǎn)設(shè)備保養(yǎng)和修理方面的考慮 l IQ、OQ & PQl Criteria for revalidation 再確認(rèn)標(biāo)準(zhǔn) 38Protocol development方案編制 For all three phases, IQ, OQ, and PQ, based on product/process requirements:對(duì)于三個(gè)階段，IQ、OQ和PQ都要基于產(chǎn)品或過(guò)程的要求： l Determine what to verify/measure 決定驗(yàn)證或測(cè)量什么 l

10、 Determine how to verify/measure 決定如何驗(yàn)證或測(cè)量 l Determine how many to verify/measure, i.e. statistical significance 決定驗(yàn)證或測(cè)量多少，如統(tǒng)計(jì)量 l Determine when to verify/measure 決定何時(shí)驗(yàn)證或測(cè)量 l Define acceptance/rejection criteria 規(guī)定接受或拒絕的標(biāo)準(zhǔn) l Define required documentation 規(guī)定要求的文件 Remember: protocol must be reviewed a

11、nd approved before execution 記住，在實(shí)施前，方案必須被評(píng)審和批準(zhǔn)。39Protocol development方案編制 Generally, protocol includes 4 sections:一般來(lái)講，方案可分為四大部分：The 1st section: validation overview, including validation scope, process description, background, worst cases, length and duration of the validation, objective etc.第一部分：

12、確認(rèn)概述部分，包含確認(rèn)范圍，過(guò)程描述，背景介紹，最差條件挑選，確認(rèn)的用時(shí)和有效期限，目標(biāo) 等等；The 2nd section: qualification readiness, including the requirements for man, machine, material, method, environment, test and label & traceability,PFMEA etc. 第二部分：鑒定準(zhǔn)備階段，包含所有的人、機(jī)、料、法、環(huán)、測(cè)及標(biāo)志和追溯,PFMEA等要求和準(zhǔn)備；The 3rd section: qualification (IQ,OQ&

13、PQ), including qualification plan and deviation disposal etc. 第三部分：鑒定階段(IQ,OQ&PQ)，包含鑒定計(jì)劃及偏差處理等；The 4th section: document requirements，including the input and output documents required by this protocol.第四部分：文件要求，包含本方案所需的文件及輸出文件要求。4041424344454647484950Some time, limits can be gotten herefrom experience and other source in advance 有時(shí)，此處可由經(jīng)驗(yàn)或其他來(lái)源預(yù)先獲得極限。5152535455565758596061PQ considerations include:PQ應(yīng)該考慮： Actual product and process parameters and procedures established in OQ OQ階段的真實(shí)產(chǎn)品、過(guò)程參數(shù)和建立的程序 Acceptabilit