GMP偏差處理中英文要點(diǎn)(共18頁(yè))

1、精選優(yōu)質(zhì)文檔-傾情為你奉上1. PURPOSE 目的Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actio

2、ns taken當(dāng)產(chǎn)品、物料或系統(tǒng)不符合質(zhì)量標(biāo)準(zhǔn)要求或某事件不符合相關(guān)文件或法規(guī)要求時(shí)，必須進(jìn)行適當(dāng)?shù)恼{(diào)查，查明原因并采取必要的改正措施。2. SCOPE 范圍This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them.本SOP適用于處理

3、所有失誤及非計(jì)劃性故障事件，含概用于產(chǎn)品并控制產(chǎn)品的化學(xué)成分、包裝材料、藥品、工藝、系統(tǒng)、設(shè)備、公共設(shè)施和廠房等。 3. DEFINITIONS/ABBREVIATIONS 定義/縮寫(xiě)Deviation（also known as anomaly）：Any unplanned change from a written procedure/document, during manufacturing or testing or a non-conformance to approved specifications or any failure on GMP-related systems.

4、Deviations are assessed according to compliance and /or the risk they present to patient health and/or with regulatory requirements. Deviations are to be classified as “critical or major or minor”偏差（通常也稱為異常）：在藥品生產(chǎn)過(guò)程中，任何與既定的程序、文件不符的非計(jì)劃的變更或與批準(zhǔn)的質(zhì)量標(biāo)準(zhǔn)不符，或與GMP相關(guān)的系統(tǒng)失敗。偏差按照對(duì)患者造成的風(fēng)險(xiǎn)何國(guó)家法規(guī)的符合性進(jìn)行評(píng)估。偏差可分為三類“嚴(yán)重偏差

5、、主要偏差、微小偏差”Critical Deviations:嚴(yán)重偏差：Critical deviations require immediate investigation, root cause analysis and corrective-preventive action.嚴(yán)重偏差需要立即進(jìn)行調(diào)查，查找問(wèn)題的根本原因并制定糾正預(yù)防措施。A deficiency in material, drug product, medical device, system or service that can affect significantly the quality, purity, s

6、afety or efficacy of a product/medical device or can lead to health threatening conditions in drug product, or medical device. Alternatively, any deficiency that can lead to a non-compliant drug product/medical device or to a situation that may be cited by regulatory authorities as critical.存在物料、產(chǎn)品、

7、醫(yī)療器械或任何系統(tǒng)、維護(hù)方面能嚴(yán)重影響產(chǎn)品質(zhì)量、純度、安全、功效，能對(duì)產(chǎn)品或身體健康產(chǎn)生危害的缺陷；或者會(huì)導(dǎo)致產(chǎn)品質(zhì)量不符合，或可能被法規(guī)部門視為嚴(yán)重缺陷項(xiàng)的缺陷；Major Deviation:主要偏差：Major deviations require investigations, root cause analysis and corrective-preventive action.主要偏差需要進(jìn)行調(diào)查，查找問(wèn)題的根本原因并制定糾正預(yù)防措施。A non-critical deviation which potentially affects the quality, purity, s

8、afety or efficacy of a product/medical device or ability to meet GMP requirements.非嚴(yán)重偏差可能潛在影響產(chǎn)品的質(zhì)量、純度、安全、功效或GMP法規(guī)的依從性。Minor Deviation：微小偏差：Minor deviation require investigation, root cause analysis and corrective-preventive action.微小偏差需要調(diào)查，查找問(wèn)題的根本原因并制定糾正預(yù)防措施。A deviation not classified as critical or

9、 major, which potentially impacts a GMP system, utility, equipment, material, component, environment or documentation, but does not affect product/medial device quality, purity, safety, or efficacy.潛在影響GMP系統(tǒng)，公用設(shè)施，設(shè)備、物料、成分、環(huán)境或文件，但不影響產(chǎn)品的質(zhì)量、純度、安全、功效，不屬于嚴(yán)重及主要偏差的缺陷。Deviations will typically, but not excl

10、usively, fall into one of the following categories:7 Confirmed Out of Specification (OOS) test results7 Controlled Zone Environmental results outside of limits7 Failure to comply with instructions in standard documents (Deviation from Standard Operating Procedures, Deviation from Batch processing pa

11、rameters during Manufacture, Packaging, labelling orTesting)7 Process or equipment failure which affects product quality 7 Reconciliation or yield outside Specification 7 Failure to comply with established program (calibration, preventive maintenance and stability test, etc)7 Material damage or cont

12、amination in storage or handling偏差通常，但不絕對(duì)，發(fā)生在以下幾個(gè)類別中:7 確認(rèn)的超出標(biāo)準(zhǔn)的測(cè)試結(jié)果7 受控區(qū)域環(huán)境超標(biāo)7 不符合標(biāo)準(zhǔn)文件規(guī)定的操作（不符合標(biāo)準(zhǔn)操作規(guī)程的操作，生產(chǎn)、包裝、貼標(biāo)簽或測(cè)試過(guò)程中操作參數(shù)的錯(cuò)誤等）7 影響產(chǎn)品質(zhì)量的操作失誤或設(shè)備故障7 物料平衡或產(chǎn)率超過(guò)限度7 物料在儲(chǔ)存或處理過(guò)程中出現(xiàn)的損壞和污染情況。7 活動(dòng)未能按照計(jì)劃進(jìn)行（校準(zhǔn)，預(yù)防性維護(hù)及穩(wěn)定性試驗(yàn)等）4. SAFETY 安全N.A. 無(wú)5. PROCEDURE 程序5.1 RESPONSIBILITIES 責(zé)任5.1.1 Manufacturing, Logistic,

13、Engineering,QC,HR Managers 生產(chǎn)、物流、工程部、QC、HR經(jīng)理¨ It is their responsibility to immediately notify to QA of the occurrence of any event that could lead to a potential failure event and to actively participate in investigation process 其職責(zé)為當(dāng)那些可能導(dǎo)致潛在失誤事件發(fā)生時(shí)，立即通知QA，并積極參與調(diào)查活動(dòng)。¨ Initiate the Quality

14、 Deviation Report. 起草質(zhì)量偏差報(bào)告¨ Implementing corrective action resulting from deviation reports when approved by the Head of Quality .執(zhí)行質(zhì)量部經(jīng)理批準(zhǔn)的偏差改正措施。¨ Ensuring all personnel in their Department are trained in the content of this SOP and know that all quality deviations are to be reported.確保

15、本部門人員接受本SOP的培訓(xùn)并清楚所有需要報(bào)告的偏差。5.1.2 Site IQC manager is responsible for 質(zhì)量部經(jīng)理負(fù)責(zé)¨ Ensuring that this SOP is maintained and complies with corporate and local GMP standards.確保本SOP始終符合集團(tuán)及中國(guó)GMP的要求。¨ Approval of corrective action resulting from deviation reports.批準(zhǔn)偏差的改正措施。¨ Approval the dispos

16、ition of the batch in case of Batch deviations.當(dāng)發(fā)生批生產(chǎn)偏差時(shí)決定批次的處理。¨ Site IQC Manager is responsible for further communication to the impacted unit and to the respective Operational Industrial Quality and Compliance (IQC) management If the failure or deviation is critical or if other sites/sub-con

17、tractors are potentially impacted.如異常事件或偏差程度嚴(yán)重或其他工廠或下級(jí)合同商可能受到影響，工廠質(zhì)量部經(jīng)理負(fù)責(zé)與受影響的單位以及相關(guān)區(qū)域質(zhì)量運(yùn)營(yíng)部進(jìn)一步溝通。¨ For critical deviations affecting product on the market, please follow the SOP “Quanlity Alert Management” ,site IQC Management is responsible to involve Industrial Quality and Compliance/Risk Man

18、agement to ensure the consistent handling of such critical deviations. 對(duì)于影響到市場(chǎng)產(chǎn)品的嚴(yán)重偏差，按照“質(zhì)量警戒的管理”，由質(zhì)量部經(jīng)理負(fù)責(zé)利用風(fēng)險(xiǎn)評(píng)估系統(tǒng)向IQC通報(bào)以確保類似嚴(yán)重偏差處理的一致性。5.1.3 QA is responsible for QA負(fù)責(zé)¨ Assure that the appropriate investigation is conducted into any failure and that an investigative report is issued to documen

19、t the situation according to the requirements of this SOP 確保每個(gè)偏差都進(jìn)行了適當(dāng)?shù)恼{(diào)查，并按本SOP要求發(fā)放偏差報(bào)告。¨ Maintaining a log of all deviation reports.保管登記所有偏差報(bào)告的日志。¨ Filing a copy of all deviation reports.將偏差報(bào)告存檔¨ Following up reports ensuring that they are closed out in a timely manner.跟蹤偏差報(bào)告確保它們及時(shí)結(jié)

20、束。¨ Reviewing all deviations of this year at least annually etc.至少每年進(jìn)行一次當(dāng)年所有偏差的審閱等。5.1.4 QC manager is responsible for QC經(jīng)理負(fù)責(zé)¨ Ensuring all test result deviations are reported according to SOP S-QC035, Out of Specification Results “OOS”.確保按照SOP S-QC035報(bào)告實(shí)驗(yàn)結(jié)果發(fā)生的偏差。¨ Perform all the tes

21、ts requested by the investigation report to investigate the cause of the deviation and/or the quality of the product.進(jìn)行調(diào)查所需的測(cè)試以配合查明原因或確定產(chǎn)品質(zhì)量。¨ Reviewing all OOS of the year at least annually and producing a report showing trends etc.至少每年進(jìn)行一次當(dāng)年所有OOS的審閱并作趨勢(shì)分析等。5.1.5 All Department Personnel are r

22、esponsible for 所有人員負(fù)有如下責(zé)任¨ Reporting all quality deviations to their Department Supervisor or Department Head.向部門主管或部門經(jīng)理報(bào)告所有質(zhì)量偏差。¨ Ensure communication to Health, Safety and Environment (HSE) if the deviation may have an impact on HSE matters.如果偏差可能影響到HSE確保通知健康、安全、環(huán)境部門。5.2 Reporting of Qua

23、lity Deviations 質(zhì)量偏差的報(bào)告5.2.1 Planned Deviations計(jì)劃性偏差Planed Deviation must not be done on an ongoing basis but exceptional use only.計(jì)劃性的偏差只能作為非常規(guī)的特例使用。Planed Deviation must be pre-authorized by QO Manager.計(jì)劃性的偏差一定要被質(zhì)量部經(jīng)理預(yù)先授權(quán)認(rèn)可。Documentation of the purpose of the deviation and approval by QO Manager i

24、s required.要求書(shū)面記錄偏差的目的以及經(jīng)質(zhì)量部經(jīng)理批準(zhǔn)。5.2.2 Unplanned Deviations 非計(jì)劃性偏差A(yù)ll instances of quality deviations must be reported immediately to the relevant area Department Manager or Supervisor.所有質(zhì)量偏差必須立即向相關(guān)的部門主管或經(jīng)理報(bào)告。The area Department is to initiate the Quality Deviation Report using the form shown in the

25、 Attachments section of this SOP. 偏差發(fā)生部門負(fù)責(zé)起草質(zhì)量偏差報(bào)告（見(jiàn)本SOP附件）5.2.3 Principles and methods 偏差處理的原則及方法5.2.3.1 Deviation initial偏差發(fā)起The following guidelines are given to assist completion of the report.以下方針用以協(xié)助報(bào)告的完成1. The Manager/Supervisor or the operator of the Department where the deviation occurred i

26、s to complete the following details in the sections 1, 2,3：發(fā)生偏差的部門的經(jīng)理/主管或發(fā)現(xiàn)偏差的操作人員應(yīng)填寫(xiě)第1、2、3、部分： In the section 1: 第1部分- Department name 部門名稱- Date raised 發(fā)現(xiàn)日期- Raised by (name) 發(fā)現(xiàn)者（姓名）In the section 2:第2部分- Product name and batch number if it is a Product failure, Equipment name if one equipment fai

27、lure or Utility name if the failure affected one utility. 若是產(chǎn)品偏差，記錄發(fā)生的產(chǎn)品名稱和批號(hào)；如果是設(shè)備誤差，記錄設(shè)備名稱；如果是影響到公共設(shè)施的偏差，記錄受影響的公共設(shè)施的名稱。In the section 3: 第3部分- Detailed explanation of the incident and the other products/batches can be affected in their quality. 誤差事故的詳細(xì)描述及可能影響到質(zhì)量的其他產(chǎn)品/批次。- Report every immediate ac

28、tion which is approved by department manager or supervisor after deviation found. 報(bào)告偏差發(fā)現(xiàn)后采取的每一個(gè)部門經(jīng)理或主管批準(zhǔn)的緊急措施。5.2.3.2 Deviation Evaluation 偏差的評(píng)估After completion of these steps the Quality Deviation Form has to be given to QA to:在這些質(zhì)量偏差報(bào)告步驟完成后交給QA以進(jìn)行：- QA should make a decision whether it is necessar

29、y to quarantine product or materials if the deviation is product or material related. The decision shall be filled in section 3 as an immediate action. 如果偏差與產(chǎn)品或物料有關(guān)，發(fā)生后QA應(yīng)立即決定是否需要立即將產(chǎn)品或物料“待檢”起來(lái)。決定應(yīng)被記錄在第3部分作為一項(xiàng)緊急措施。- Fill the section 4 and record in the Deviations logbook.填寫(xiě)第4部分并在日志中登記。- Call and org

30、anize a meeting with the involved Department Manager / Supervisor and all other functions that can help in discussing and set the investigation to find the cause(s) of the failure/deviation 召集所有相關(guān)部門的經(jīng)理/主管以及其他對(duì)于討論并找出偏差的原因有幫助的職能部門人員開(kāi)會(huì)。- During the investigation the extent of the problem, for example,

31、implications for previous or subsequent batches of the same/other product(s) should be taken into consideration, as well as, depending on the nature of the deviation, it may be necessary to execute additional stability studies and so on. Report the investigation observation in the section 5 of the f

32、orm Quality Deviation Report. Attach to the form all the memos, e-mails and so on related to the problem.在調(diào)查過(guò)程中，要考慮問(wèn)題的擴(kuò)展程度，比如是否牽涉相同/不同產(chǎn)品的前幾批或后幾批；還有，依據(jù)偏差的性質(zhì)，可能需要進(jìn)行額外的穩(wěn)定性試驗(yàn)等。在質(zhì)量偏差報(bào)告的第5部分報(bào)告調(diào)查的發(fā)現(xiàn)。將所有與調(diào)查有關(guān)的備忘、電子郵件等等附在報(bào)告上。The deviation evaluation is based on the comparison to the safty risk evaluation and

33、 capability to detect the defect偏差評(píng)估應(yīng)基于對(duì)質(zhì)量安全風(fēng)險(xiǎn)的評(píng)估及缺陷被發(fā)現(xiàn)的可能性的綜合評(píng)價(jià)。The severity of the impact is defined as per below descriptions:嚴(yán)重性等級(jí)分類描述如下：Rating等級(jí)Classification分類Description描述1Minor微小Compliance with dossier/cGMP but increase risk for complaints符合注冊(cè)文件及現(xiàn)行GMP的要求，但增加投訴的風(fēng)險(xiǎn)Or/and defect leading to prod

34、ucts that do not cause any adverse health reaction. They may pose a constraint for the user or may impair the market imagine of the products.和/或缺陷導(dǎo)致產(chǎn)品不會(huì)對(duì)健康產(chǎn)生任何不良影響，但可能致產(chǎn)品使用受到限制或影響產(chǎn)品形象。2Moderate一般Non compliance with dossier /cGMP ; no or minor influence on product quality(safety , efficiency)；不符合注冊(cè)文件

35、或現(xiàn)行GMP要求，對(duì)產(chǎn)品質(zhì)量無(wú)影響或微小影響；Or and defects ,which may not pose a significant hazard to health but where a recall could be initiated (perhaps not required by the competent authority) for other reasons, but are not class 1 or 2;和/或缺陷，不會(huì)對(duì)健康產(chǎn)生嚴(yán)重影響但可能會(huì)因其他原因發(fā)起召回（可能不會(huì)被法規(guī)部門要求），但不屬于1、2類缺陷；A situation in which use

36、 of or exposure to a compromised product is not likely to cause adverse health consequences；使用或讓步使用的情形不會(huì)對(duì)公眾健康產(chǎn)生不良影響；4Major關(guān)鍵Non compliance with dossier /cGMP ; major influence on product quality(safety , efficiency)；不符合注冊(cè)文件或現(xiàn)行GMP要求，對(duì)產(chǎn)品質(zhì)量（安全、功效）產(chǎn)生重大影響；Or and defects ,which could cause illness or mist

37、reatment, but are not class 1;和/或缺陷，可能導(dǎo)致疾病或錯(cuò)誤治療，但不屬于一類缺陷；A situation in which use of or exposure to a compromised product may cause temporary or medically reversible adverse health consequences is remote；使用或讓步使用的情形對(duì)患者健康產(chǎn)生臨時(shí)或可逆的治療不利影響的可能極??；5Severe嚴(yán)重Non compliance with dossier /cGMP ; critical influen

38、ce on product quality(safety , efficiency)；不符合注冊(cè)文件或現(xiàn)行GMP要求，對(duì)產(chǎn)品質(zhì)量（安全、功效）產(chǎn)生嚴(yán)重影響；Or/ and defects ,which are potentially life threading or could cause serious risk to health;和/或缺陷，對(duì)生命存在潛在威脅或可能導(dǎo)致對(duì)健康產(chǎn)生嚴(yán)重風(fēng)險(xiǎn)；A situation in which there is a reasonable probability that the use of or exposure to a compromised

39、product will cause serious adverse health consequences or death.有依據(jù)可證明使用或讓步使用的情形對(duì)健康產(chǎn)生嚴(yán)重不良影響或致死；The occurrence definitions are proposed: 可能性分類如下：Rating等級(jí)Occurrence可能性Description描述1Extremely rare/very unlikely極少/幾乎不可能Very unlikely 幾乎不可能First time that the event is observed第一次發(fā)現(xiàn)此事件2Remote/rare微乎其微/很少Ra

40、re很少Isolated in the concerned batch在相關(guān)的批次中獨(dú)立3Occasional偶爾Possible, do not expect reoccurrence可能，不希望再次發(fā)生Event observed 0 to 1 time a month/a campaign or/and isolated cluster in the concerned batch在一個(gè)月內(nèi)或一個(gè)批組內(nèi)內(nèi)發(fā)生0-1次的事件，或在不連續(xù)的批次內(nèi)發(fā)生。4Likely可能Probable, possible reoccurrence很可能，可能再次發(fā)生Event observed 2 to 3

41、 times a month/a campaign or/and Unpredictable number of units impacted in the concerned batch在一個(gè)月內(nèi)或一個(gè)批組內(nèi)內(nèi)發(fā)生2-3次的事件，或在相關(guān)的批次內(nèi)不可預(yù)知發(fā)生的次數(shù)。5Almost certain or unknown 幾乎肯定會(huì)發(fā)生/不能確定Frequent to permanent, or unknown occurrence頻繁固定的發(fā)生，或不可知發(fā)生性Event observed 4 to 5 times a month/a campaign or/and previous and/o

42、r following batches also impacted.在一個(gè)月內(nèi)或一個(gè)批組內(nèi)內(nèi)發(fā)生4-5次的事件，或在后續(xù)的批次也深受影響的。The safety risk level is given by multiplying the severity of impact and the likelihood of occurrence. The result is compared to the following chart:質(zhì)量風(fēng)險(xiǎn)嚴(yán)重等級(jí)來(lái)自于缺陷的嚴(yán)重性及發(fā)生的可能性的乘積，結(jié)論見(jiàn)下表：Severity of impactMinor 1Moderate 2Major 4Sever

43、 5Likelihood of OccurrenceAlmost certain or even unknown 55102025 Likely 4481620Occasional 3361215Remote 224810Extremely rare 11245Based on the results given in the above chart, the safety risk level is evaluated:Low if the number is 4（green area）Moderate if the number is 3 and 10 (orange area)High

44、if the number is 8 (red area)根據(jù)上表，質(zhì)量風(fēng)險(xiǎn)嚴(yán)重等級(jí)為：如果乘積小于4（綠色區(qū)域）為低；如果乘積大于3而小于10（黃色區(qū)域）為中；如果乘積大于8（紅色區(qū)域）為高；The Detection definitions are proposed: 可發(fā)現(xiàn)性分類如下： Rating等級(jí)Detection可發(fā)現(xiàn)性Description描述1High 高100% control with a performance close to 100%;100%控制性能指標(biāo)，檢查接近100%High probability to detect and reject the defec

45、t 發(fā)現(xiàn)并剔除缺陷產(chǎn)品的可能性很高；2moderate100%c control with a performance significantly different to 100% or partial control (e.g. IPC, statistical);100%控制性能指標(biāo)，大量檢查但不能100%檢查或采用部分檢查（如：IPC, 數(shù)理統(tǒng)計(jì)等）；Would most probably be detected during distribution or by the handler (health care professional ) or by the patient (od

46、our, color, appearance)在銷售或處理（醫(yī)務(wù)人員）或患者（品種，顏色，外觀）等極有可能被發(fā)現(xiàn)的；3lowLow probability to detect, most likely by random chance.發(fā)現(xiàn)的可能性很低，可能會(huì)被很偶然的機(jī)會(huì)發(fā)現(xiàn)Would most probably not be detected before the use在使用前幾乎不可能被發(fā)現(xiàn)Severity risk level質(zhì)量風(fēng)險(xiǎn)的嚴(yán)重等級(jí)Low 1Moderate 2High 3 Probability of detection可發(fā)現(xiàn)性Low 1369Moderate 2246

47、High 3123Based on the results given in the above chart, the deviation is evaluated:Minor if the number is 3（green area）Major if the number is 2and 6 (orange area)Critical if the number is 4 (red area)根據(jù)上表的結(jié)果，偏差等級(jí)評(píng)估為：如果兩者乘積小于3（綠色區(qū)域）為微小偏差；如果兩者乘積大于2，小于6（黃色區(qū)域）為主要偏差；如果兩者乘積大于4（紅色區(qū)域）為嚴(yán)重偏差；When investigatio

48、n has been finished, department manager shall fill evaluation of investigation and immediate actions, and QA make batch determination, if the deviation is product related, in section 5. 當(dāng)調(diào)查結(jié)束后部門經(jīng)理應(yīng)在第5部分填寫(xiě)對(duì)調(diào)查和緊急措施的評(píng)價(jià)，如果偏差與產(chǎn)品有關(guān)，QA同時(shí)做出批次處理決定。According to the classification of deviation and the evaluati

49、on, QA tick the type of the deviation in section 5 as “critical /major and minor”.根據(jù)偏差的分類及對(duì)本偏差的評(píng)價(jià)結(jié)果，由QA 在偏差報(bào)告表的第五部分偏差類型“嚴(yán)重/主要/微小”打勾做好標(biāo)記。5.2.3.3 Corrective action and preventive action 糾正預(yù)防措施After the investigation has been completed, the department manager/supervisor has to report in the section 6 o

50、f the form the recommended corrective actions identified, clarify who is responsible for each action and the due date. The corrective action must be approved and signed by Quality manager. 在調(diào)查結(jié)束后，部門經(jīng)理/主管必須在第6部分中記錄建議的改正措施，明確各項(xiàng)活動(dòng)的負(fù)責(zé)人和預(yù)期完成時(shí)間。質(zhì)量部經(jīng)理將批準(zhǔn)改正措施并簽字。The investigation and the corrective action(s

51、) plan (from step 1 to 6) must be completed within 30 business days. If this time is exceeded, it must be justified by the involved Departments manager and QA, and an action plan with time commitments must be issued. All deviations investigations exceeding 30 business days must be notified to the Qu

52、ality and Site Manager and justification filled in section 6.所有調(diào)查和改正措施的確定（自第1到6步）必須在30個(gè)工作日之內(nèi)完成。如果超時(shí)，必須由相關(guān)部門經(jīng)理及QA判斷是否事出有因，同時(shí)必須給出行動(dòng)計(jì)劃的時(shí)間承諾。所有超過(guò)30天的偏差調(diào)查必須通報(bào)質(zhì)量部經(jīng)理和廠長(zhǎng)并且將合理解釋填寫(xiě)于第6部分。 As soon as the corrective actions have been implemented the responsible person for each action has to fill the section 7 of

53、 the Deviation form and his manager review the actual work.在改正措施完成后責(zé)任人填寫(xiě)偏差報(bào)告第7部分同時(shí)部門經(jīng)理復(fù)核實(shí)際的情況。All the documents and reports should be attached to the Deviation form. 所有文件和報(bào)告應(yīng)附在偏差報(bào)告后。After all the corrective actions have been completed the Department(s) Manager(s) and the QO Manager have to sign the

54、section 8 for approval and forward the form to QA for filing. 在所有改正措施完成后，部門經(jīng)理應(yīng)對(duì)所有措施進(jìn)行評(píng)價(jià)并和質(zhì)量部經(jīng)理在第8部分簽字并送交QA存檔。For Unplanned Bach Deviation, the corrective actions may include reprocessing. Please follow SOP QA007 （Reprocessing Procedure）to perform such actions. All the further reprocessing must pre-a

55、uthorized by QO Manager and documents should be filled together with their Batch Record Sheet or Packing Record Sheet.對(duì)于非計(jì)劃性批生產(chǎn)偏差，改正措施可能包括再處理。操作時(shí)請(qǐng)遵守SOP QA007(再處理程序)進(jìn)行。所有進(jìn)一步的返工或再處理必須由質(zhì)量部經(jīng)理預(yù)先授權(quán)，文件應(yīng)和批生產(chǎn)紀(jì)錄或批包裝記錄一起存檔。 If change involved in the correction action of a deviation, a change control should be implement according to SOP QA003.如果偏差制定的糾正、預(yù)防措施為永久性措施的，涉及到變更，要遵守QA003（變更控制）。5.3 Filing of Deviation Reports 偏差報(bào)告的存檔