Senior management Name Function Telephones/fax
高級(jí)管理 姓名 崗位 電話/傳真
Production Head 略
b. Telephone (24/24) and fax numbers.
The CCC Quality System is based on the requirements of the EU Guidelines, the Code of Federal Regulations Q7A and local GMP requirements.
The Quality System involves the integration of all functions on the site to achieve the legal, standard and company requirements.
A fully documented quality system is established and maintained which ensures that products and / or services that are bought, produced, released and sold meet the specified requirements of the relevant specifications and / or contract and ultimately the requirements of the manufacturing license.
建立并保持了完整的質(zhì)量系統(tǒng)文件，以確保所購(gòu)買(mǎi)、生產(chǎn)、放行及銷(xiāo)售的產(chǎn)品或服務(wù)符合相關(guān)標(biāo)準(zhǔn)所指定的要求，從而最終滿足生產(chǎn)許可的要求。
The Quality Unit performs regular internal quality audits. The results of every audit are documented and reviewed.
質(zhì)量部門(mén)執(zhí)行定期的內(nèi)部質(zhì)量審計(jì)。每一次審計(jì)結(jié)果都記錄并且經(jīng)過(guò)審核。
A system for corrective and preventive actions (CAPA) is in place to ensure continuous improvement of all quality related operations and systems.
Annual Management Reviews are held, deviations are discussed and action taken accordingly.
The Quality Unit is also responsible for handling product quality complaints and product recalls.
2. Personnel
人員
2.1 Employees
員工
Activity Number of employees
活動(dòng) 員工數(shù)量
Purchasing 5
采購(gòu)
Production Site Services 300
生產(chǎn)人員
[注：直譯為生產(chǎn)廠地服務(wù)，也就是服務(wù)于生產(chǎn)的人員，所以應(yīng)該指直接從事藥品生產(chǎn)的人員]
Technical Support 10
技術(shù)支持
Quality Control 26
質(zhì)量控制
Quality Assurance 15
質(zhì)量保證
Storage / Distribution 6
貯存/分發(fā)
Others
其它
Total: 略
總?cè)藬?shù)
2.2 Organization chart and key personnel
組織機(jī)構(gòu)圖及關(guān)鍵人員
Name, first name------------Function--------------------Experience in Pharma---------Initial education
姓名------------------------崗位------------------------從事藥品生產(chǎn)的經(jīng)歷-----------第一學(xué)歷
XX--------------------------Head of Production----------10---------------------------Undergraduate
XX--------------------------生產(chǎn)領(lǐng)導(dǎo)
XX--------------------------Managing Director-----------XX---------------------------XX
XX--------------------------管理主管
XX--------------------------Head of QC------------------XX---------------------------XX
XX--------------------------QC領(lǐng)導(dǎo)
XX--------------------------Head of QA------------------XX---------------------------XX
XX--------------------------QA領(lǐng)導(dǎo)
XX--------------------------Head of Engineering---------XX---------------------------XX
XX--------------------------工程領(lǐng)導(dǎo)
[注：Experience in Pharma是指從事藥品生產(chǎn)的工作年限。此處需要附一張組織機(jī)構(gòu)方框圖]2.3 Training
培訓(xùn)
The Human Resources department is responsible for determining the internal and external training needs of all staff. An annual training program is developed from these needs and is approved by the Technical Director and the Head of Quality.
人力資源部負(fù)責(zé)所有人員內(nèi)部和外部的培訓(xùn)要求。根據(jù)這些要求制訂的年度培訓(xùn)計(jì)劃由技術(shù)主管和質(zhì)量部門(mén)的領(lǐng)導(dǎo)批準(zhǔn)。
Training is considered as one of the essential features in the management of human resources. Each production unit has the responsibility for identifying the necessary training or retraining required for a given job. As a minimum, training consists of the basic understanding of cGMP requirements and understanding all Standard Operating Procedures (SOPs) applicable to the specific job.
培訓(xùn)是人力資源管理中基本要素之一。每一個(gè)生產(chǎn)單位有責(zé)任去識(shí)別一個(gè)崗位所必需的培訓(xùn)或再培訓(xùn)要求。培訓(xùn)至少包括對(duì)cGMP基本要求以及適用于指定崗位的所有標(biāo)準(zhǔn)操作規(guī)程的理解。
[注：這里是指應(yīng)該向員工強(qiáng)調(diào)cGMP的概念及其基本要求，并且要熟知各自的崗位SOP]To all new employees an initial training is provided, including discussion on the relevant regulations or guidelines and SOPs. The continuous training program is based on the needs of the personnel, while taking into account the requirements determined by the company‘s policy and the management of the department.
對(duì)所有的新員工進(jìn)行進(jìn)廠培訓(xùn)，包括相關(guān)法規(guī)或指導(dǎo)方針以及SOPs的討論。后續(xù)的培訓(xùn)是基于人員的需要，同時(shí)考慮公司的政策以及部門(mén)管理的要求。
[注：initial training直譯為最初的培訓(xùn)，對(duì)于制藥企業(yè)而言，應(yīng)該就是指進(jìn)廠培訓(xùn)]General cGMP training is provided to all employees. Training typically includes guidelines or procedures concerning cGMPs for production, packaging and testing. Training programs are examinable to assess the training effectiveness.
對(duì)所有員工進(jìn)行總的cGMP培訓(xùn)。培訓(xùn)通常包括cGMP中與生產(chǎn)、包裝和測(cè)試有關(guān)的指導(dǎo)方針或程序。對(duì)培訓(xùn)程序進(jìn)行檢查以評(píng)估培訓(xùn)的效果。
Records of all training courses attended are compiled and retained.
所有培訓(xùn)課程的記錄需要進(jìn)行匯編并保留。
Type of training: ---------------------------------------------------Employees concerned
培訓(xùn)類(lèi)型：-----------------------------------------------------------涉及到的員工
Basic training: -----------------------------------------------------All new employees
基礎(chǔ)培訓(xùn): -----------------------------------------------------------所有新員工
Basic GMP training: -------------------------------------------------Those identified
基礎(chǔ)GMP培訓(xùn)：--------------------------------------------------------指定人員
GMP refresher training: ---------------------------------------------Those identified
GMP進(jìn)修培訓(xùn)：--------------------------------------------------------指定人員
Continuous training to assigned duties: -----------------------------All employees
指定職責(zé)的繼續(xù)培訓(xùn)：-------------------------------------------------所有員工
2.4 Health and hygiene requirements for personnel
人員的健康與衛(wèi)生要求
2.4.1 Personnel hygiene requirements including clothing
包括衣服在內(nèi)的人員衛(wèi)生要求
The production units provide suitable and sufficient areas for washing and cleaning. All associates involved in the production, packaging or testing are provided with the necessary clothing for the respective function.
生產(chǎn)單位為清洗與清潔提供合適并足夠的區(qū)域。根據(jù)生產(chǎn)、包裝或檢測(cè)各崗位的需求，為所有相關(guān)崗位的人員提供必需的服裝。
In all Production and Storage areas protective clothing is issued to personnel. Hairnets and overshoes are provided to minimize contamination.
在所有生產(chǎn)及貯存區(qū)，給人員提供保護(hù)服裝。提供發(fā)套及套鞋以最大程度地減小污染。
Clothing is changed regularly and use is made of an external laundry service.
定期更換服裝并交由外部洗衣店清洗。
[注：各崗位服裝的配備、清洗等需根據(jù)各公司的實(shí)際操作進(jìn)行描述]2.4.2 Health requirements for personnel
人員的衛(wèi)生要求
A basic pre-employment medical examination is undertaken for all employees.
對(duì)所有員工進(jìn)行基本的就業(yè)前體檢。
Routine basic medical examination on a periodic basis is performed on employees. This is part of the health surveillance program.
員工基本的體檢通常定期執(zhí)行。這是健康監(jiān)督檢查的一部分。
It is the responsibility of the department head to ensure that all employees are working in a healthy environment. The staff is required to report any potential risk or sickness/ disease to the department head immediately.
The employee will only return to work when advised to do so by the Health Center Staff.
部門(mén)領(lǐng)導(dǎo)有責(zé)任確保所有的員工在一個(gè)健康的環(huán)境中工作。要求全體員工要立即向部門(mén)領(lǐng)導(dǎo)匯報(bào)任何潛在的風(fēng)險(xiǎn)或疾病。經(jīng)治愈的員工只有經(jīng)健康中心許可才能重新上崗。
[注：對(duì)于制藥企業(yè)而言，這里的疾病應(yīng)該指?jìng)魅拘缘募膊?。最后一句直譯似乎不妥，因此根據(jù)實(shí)際情況進(jìn)行了意譯]3. Premises and Equipment
廠房與設(shè)備
3.1 Plans
平面圖
3.1.1 General Location of the Site
廠地位置
The CCC manufacturing facility is located in an industrial area. The site consists of XXX buildings containing all activities.
公司的生產(chǎn)區(qū)位于工業(yè)區(qū)，廠地由包括了所有生產(chǎn)活動(dòng)的X個(gè)建筑物組成。
3.1.2 Site and Building Plan
廠地與建筑物平面圖
The general plan of buildings located on the site is contained in ATTACHMENT. The factory building six years old and was designed according to current Good Manufacturing standards.
廠地建筑物位置平面圖見(jiàn)附件。該建筑物有6年的歷史且是根據(jù)現(xiàn)行良好的生產(chǎn)標(biāo)準(zhǔn)進(jìn)行設(shè)計(jì)的。
3.1.3 Detailed Building Plans
Detailed building plans are contained in ATTACHMENT. The following key activities are indicated.
建筑物平面圖詳細(xì)說(shuō)明見(jiàn)附件。指明下面一些關(guān)鍵的活動(dòng)區(qū)：
Goods receiving and packaging material storage
貨物的接收與包裝物料的貯存
Raw material storage
原料的貯存
Milling
粉碎
Weighing
稱(chēng)量
Dispensary
配料
Non sterile API production
非無(wú)菌API產(chǎn)品
Primary Packaging
內(nèi)包裝
Secondary Packaging
外包裝
QC laboratory
QC實(shí)驗(yàn)室
Storage areas
貯存區(qū)
Dispatch warehouse
倉(cāng)庫(kù)分發(fā)
Office, staff and administration areas
辦公室，人員和管理區(qū)
3.1.4 Personnel, Material and Product Flows
人員，原料與產(chǎn)品的流向
Material and personnel flows are contained in ATTACHMENT.
人流與物流圖見(jiàn)附件
3.2 Production and Packaging Areas
生產(chǎn)與包裝區(qū)
The following table lists different operations together with the total surface and room number of the corresponding areas.
下表中列出了不同操作以及相應(yīng)區(qū)域的總表面積與房間數(shù)
Type of training --------------------Product XX
類(lèi)型---------------------------------產(chǎn)品XX
Operations concerned-----------------e.g. Reaction and Filtration, Centrifugation and Sieving, Drying,
有關(guān)的操作---------------------------Filling and Packaging如反應(yīng)與過(guò)濾,離心與過(guò)篩,干燥,填充與包裝
Total surface (m²)-------------------500
總表面積
Number of rooms----------------------10
房間數(shù)
3.3 Premises mentioned by building references and activities
所提及廠房的建筑特性及其所執(zhí)行的功能
[注：根據(jù)實(shí)際廠房情況按此表進(jìn)行填寫(xiě)，還可包括留樣室、QC實(shí)驗(yàn)室、稱(chēng)量室、倉(cāng)庫(kù)等的具體情況]3.4 Water
Quality Control or Production Personnel who had special education and training will perform the sampling of the water according to the sampling Standard Operation Procedure from predefined sampling points.
水的取樣由經(jīng)過(guò)專(zhuān)門(mén)教育與培訓(xùn)的質(zhì)控或生產(chǎn)人員執(zhí)行，根據(jù)取樣標(biāo)準(zhǔn)操作規(guī)程按預(yù)先指定的取樣點(diǎn)進(jìn)行取樣。
City Water and Purified Water are used in the process of API A. Purified Water is prepared by a validated water purification system. Purified water is sampled at an interval of 7 days and tested according to Ph.Eur purified water specifications.
在原料藥A的生產(chǎn)過(guò)程中使用到了城市用水與純化水。純化水由一經(jīng)過(guò)驗(yàn)證的水純化系統(tǒng)制備，每隔7天取樣一次，并按歐洲藥典純化水規(guī)格進(jìn)行檢測(cè)。
City water supplied by local Water Supply Corporation is tested according to the in-house specifications every 15 days.
由當(dāng)?shù)刈詠?lái)水公司提供的城市用水根據(jù)內(nèi)控規(guī)格每15天檢測(cè)一次。
[注：城市用水的來(lái)源必須符合實(shí)情，水的檢測(cè)周期也必須符合公司的SOP要求。此處需以表格的形式列出純化水及城市用水的質(zhì)量規(guī)格，并明確行動(dòng)限與警戒限]3.5 Manufacturing Equipment
生產(chǎn)設(shè)備
[注：也就是設(shè)備清單，以表格的形式列出生產(chǎn)中所使用主要設(shè)備的設(shè)備名稱(chēng)、生產(chǎn)者、數(shù)量、容量、安裝年限等，如離心機(jī)、壓力過(guò)濾器、結(jié)晶釜、反應(yīng)釜、粉碎篩]3.6 Control Laboratory Equipment
實(shí)驗(yàn)室控制設(shè)備
All major pieces of quality control laboratory equipment are serviced and calibrated at regular intervals depending on the specific item. Service and calibration is documented in logbooks.
The following table references the equipment used for IPC and finished product testing during production:
對(duì)QC實(shí)驗(yàn)室設(shè)備的所有主要部件按規(guī)定的項(xiàng)目進(jìn)行定期維護(hù)與校正，維護(hù)與校正情況在日志本上進(jìn)行記錄。
[注：列一份QC實(shí)驗(yàn)室的設(shè)備清單，內(nèi)容包括設(shè)備名稱(chēng)、房間號(hào)、數(shù)量及安裝年限等]3.7 Maintenance and Calibration
保養(yǎng)與校正
4. Production
生產(chǎn)
4.1 Process Flow
工藝流程
Process flow diagrams for A API manufactured on the site, are contained in ATTACHMENT.
原料藥A的生產(chǎn)工藝圖見(jiàn)附件。
[注：附一張工藝流程圖]
4.2 Operations for handling materials and products
原料和產(chǎn)品的操作或處理
Operation or handling------------------------------Responsible Department-----------------------Remarks
操作或處理-----------------------------------------負(fù)責(zé)部門(mén)---------------------------------------備注
Receipt Raterials/Products-------------------------Warehouse-------------------------------------NA
原料/產(chǎn)品的接收------------------------------------倉(cāng)庫(kù)
Quarantine Raterials/Products----------------------Warehouse--------------------------------------NA
原料/產(chǎn)品隔離--------------------------------------倉(cāng)庫(kù)
Sampling Raterials/Products-------------------------QA
原料/產(chǎn)品取樣--------------------------------------質(zhì)量保證部-------------------------------------NA
Manufacturing -------------------------------------Production-------------------------------------NA
生產(chǎn)-----------------------------------------------生產(chǎn)部門(mén)
Packaging------------------------------------------Production------------------------------------NA
包裝-----------------------------------------------生產(chǎn)部
Quarantine API-------------------------------------Warehouse--------------------------------------NA
API隔離--------------------------------------------倉(cāng)庫(kù)
Storage/Distribution API---------------------------Warehouse--------------------------------------NA
API貯存/分發(fā)---------------------------------------倉(cāng)庫(kù)
4.3 Rejected materials and products
原料和產(chǎn)品的拒收
Rejected materials are stored isolated in separate containers, which are accordingly labeled as rejected material..
拒收的原料貯存在單獨(dú)的容器中，容器上貼有拒收標(biāo)簽。
The material is transferred to a separate area. Quality department decides about reprocessing or waste disposal.
該原料被轉(zhuǎn)移到獨(dú)立的區(qū)域，由質(zhì)量部門(mén)決定是否返工或作為廢物處理。
Materials, which fail to meet the specification, are documented in an appropriate document (i.e. analytical report). The document is attached for the finished material to the batch production record.
不符合質(zhì)量規(guī)格的原料以一種適當(dāng)?shù)奈募ㄈ鐧z驗(yàn)報(bào)告）進(jìn)行存檔。這份文件附在最終產(chǎn)品的批生產(chǎn)記錄中。
4.4 Validated Processes
工藝驗(yàn)證
CCC has validated all of the processes related to the manufacturing and testing of API per the M-aster Validation Plan.
See ATTACHMENT 12 for Validated Processes
公司按驗(yàn)證主計(jì)劃對(duì)與原料藥的生產(chǎn)和測(cè)試有關(guān)的所有工藝都進(jìn)行了驗(yàn)證。
Scope of Validation
驗(yàn)證范圍
Process Validation, Analytical Methods, Raw Material Testing, Product testing, Validation of Utilities, Cleaning Validation
工藝驗(yàn)證、分析方法、原料測(cè)試、產(chǎn)品測(cè)試、設(shè)備驗(yàn)證、清潔驗(yàn)證
5. Documentation
文件
5.1 General
總則
All Documentation required by GMP Regulation is issued, managed and controlled by a Document Management System such as batch related documents as M-aster Batch Records - Processing and Packaging Instructions, Raw Data Records, Distribution Records, Standard Operating Procedures, Specifications, Test Methods and non batch related documents such as Qualification and Validation Documents, Complaint and Recalls Records, Environmental Monitoring Records, Utility Monitoring Records, Change Control Documentation, Engineering Drawings, Maintenance and Calibration Records, Equipment Logs, Personnel Training Records, Technical Agreements, Investigation and Reporting Records, Cleaning and Sanitization Records, Entry Records for Controlled Areas, Pest Control Records, Stability Records, Audit Reports, Regulatory Files, etc.
按GMP法規(guī)要求制訂的所有文件由文件管理系統(tǒng)發(fā)行、管理與控制，例如與批生產(chǎn)有關(guān)的文件，如批生產(chǎn)記錄，生產(chǎn)與包裝說(shuō)明，原始數(shù)據(jù)記錄，分發(fā)記錄，標(biāo)準(zhǔn)操作程序，規(guī)格，檢測(cè)方法；與批生產(chǎn)無(wú)關(guān)的文件，如確認(rèn)與驗(yàn)證文件，投訴與召回記錄，環(huán)境監(jiān)測(cè)記錄，設(shè)備監(jiān)控記錄，變更控制記錄，工程圖紙，保養(yǎng)與校正記錄，設(shè)備日志，人員培訓(xùn)記錄，技術(shù)協(xié)議，調(diào)查研究與報(bào)告記錄，清潔與衛(wèi)生記錄，控制區(qū)人員出入記錄，蚊蟲(chóng)控制記錄，穩(wěn)定性記錄，審計(jì)記錄，法規(guī)文件等。
Modifications to M-aster Documents are managed through Change Control.
主文件的修訂按變更控制程序進(jìn)行管理。
All incoming raw materials are quarantined until all the tests required by the specification have been performed and found to be satisfactory.
所有進(jìn)廠的原料被隔離，直到按照指定的規(guī)格進(jìn)行檢測(cè)并且所有檢測(cè)結(jié)果均符合要求。
A numbered copy of the M-aster batch production record is produced for every batch which serves as an Operating Procedure.
將主批生產(chǎn)記錄編號(hào)后的副本，按操作程序填寫(xiě)每批的批生產(chǎn)記錄。（總是難以翻譯順暢）
The guidelines used in the packaging and labeling of APIs are defined in approved packaging assembly specifications. The packaging orders are prepared for specified quantities, and whenever possible, an entire batch is packaged at one time. The packaging is performed in a manner such as to avoid mix-ups and prevent cross contamination.
批準(zhǔn)的包裝規(guī)格中規(guī)定了APIs包裝與貼簽的準(zhǔn)則。包裝量按規(guī)定的數(shù)量準(zhǔn)備，無(wú)論如何，一個(gè)完整的批號(hào)應(yīng)在一個(gè)時(shí)間內(nèi)包裝完成。包裝以一種方式進(jìn)行，以避免混批以及預(yù)防交叉污染。
Adequate sampling and controls are set for all the critical process steps for each product to ensure that each operation is satisfactory.
每一批生產(chǎn)中所有關(guān)鍵工藝步驟要設(shè)定足夠的取樣與控制，以保證每一批的操作是令人滿意的。
Representative samples of the batch are sampled at various intervals during production and processing to ensure quality of the final product.
在生產(chǎn)與操作過(guò)程中，以不同的間隔對(duì)生產(chǎn)批的代表性樣品進(jìn)行取樣，以確保最終產(chǎn)品的質(zhì)量。
5.2 SOPs
標(biāo)準(zhǔn)操作程序
A list of all SOPs.
所有SOP的列表
[注：以附錄的形式提供一份與生產(chǎn)有關(guān)的所有SOP的目錄](méi)6. Quality Control
質(zhì)量控制
6.1 Release of batches
批放行
Name and function of the person who have responsibility for the release of Packaging materials, Bulk Products, Raw Material: XX, QA manager
負(fù)責(zé)包裝材料、原料藥產(chǎn)品、原輔料的人及其崗位
6.2 Brief description of Quality Control System
質(zhì)量控制系統(tǒng)簡(jiǎn)述
Quality Control has a well-equipped laboratory for the physical, analytical and microbiological testing of raw materials, intermediates and Finished API.
質(zhì)量控制部門(mén)有一個(gè)設(shè)備完善的實(shí)驗(yàn)室，負(fù)責(zé)對(duì)原料、中間體以及原料藥產(chǎn)品進(jìn)行物理、化學(xué)及微生物檢測(cè)。
A Quality Control sampler takes samples in a sampling booth according to specific sampling plans.
質(zhì)量控制部門(mén)的取樣員根據(jù)規(guī)定的取樣計(jì)劃在取樣間進(jìn)行取樣。
The samples are logged into the laboratory and allocated to the relevant section for testing.
所取樣品在實(shí)驗(yàn)室登記并分發(fā)到相關(guān)的檢測(cè)崗位。
Materials and products are tested according to registered testing specifications. Methods have been validated according to the M-aster Validation Program.
原料及產(chǎn)品根據(jù)已注冊(cè)的測(cè)試規(guī)格進(jìn)行測(cè)試。檢測(cè)方法已根據(jù)驗(yàn)證主計(jì)劃進(jìn)行了驗(yàn)證。
Results are reported on a Laboratory Test sheets and supplied to the relevant Supervisor who reviews the results and gives a final disposition on the material or product tested.
檢測(cè)結(jié)果報(bào)告在實(shí)驗(yàn)室的測(cè)試單上，提供給相關(guān)的負(fù)責(zé)結(jié)果審核的管理者并對(duì)原料或產(chǎn)品的測(cè)試結(jié)果給出一個(gè)最終的處理。
Release of products entails a Batch Record and Quality Control documentation reviewed prior to release.
產(chǎn)品的放行需要一個(gè)批記錄以及先前被審核放行的質(zhì)量控制部門(mén)的文件。
[注：我理解為需要批記錄以及QC的質(zhì)量檢驗(yàn)合格報(bào)告單才能放行]
7. Distribution, Complaints and Product Recalls
分發(fā)、投訴與產(chǎn)品召回
A procedure is established for the handling of customer complaints and product recalls. The site SOPs describe all necessary steps, starting from the notification recording, investigation and subsequent actions, which must be carried out for any customer complaint received and potential recall. The content of the investigation include Batch Production Record, retest of reserve samples and test of samples provided by customers. All related complaints and recalls must be recorded, including product name, batch number, receiving date, cause of recall, etc.
建立客戶投訴與召回的處理程序。廠地SOPs描述了所有必要的步驟，從通知記錄，調(diào)查以及后來(lái)的行動(dòng)開(kāi)始，收到的任何客戶投訴以及潛在的召回都必須實(shí)施。調(diào)查內(nèi)容包括批生產(chǎn)記錄、留樣樣品的復(fù)測(cè)以及客戶提供樣品的測(cè)試。必須記錄所有的投訴與召回，包括產(chǎn)品名稱(chēng)，批號(hào)，收到日期，召回的原因等。
8. Self-inspections
自檢
In order to monitor the implementation of good manufacturing practice, any necessary corrective measures and regular internal audits are performed in accordance with an approved schedule. A full general GMP inspection is carried out in each year. In addition, inspections for parts of GMP system will be carried out every month.
為了監(jiān)控GMP的執(zhí)行情況，應(yīng)根據(jù)批準(zhǔn)的時(shí)間表執(zhí)行任何必要的糾正措施以及定期的內(nèi)部審計(jì)。每年執(zhí)行一次全面的GMP檢查，另外，每個(gè)月執(zhí)行一次GMP系統(tǒng)的部分檢查。
When the self-inspection has been completed, QA will discuss the deficiencies observed during the inspection with representatives of the departments. Corrective actions will be completed in a timely and effective manner under the supervision of QA. Audit findings and corrective actions will be documented.
自檢完成后，QA將與相關(guān)的部門(mén)討論審計(jì)中所發(fā)現(xiàn)的缺陷，在QA的監(jiān)督下以及時(shí)、有效的方式完成糾正行動(dòng)。審計(jì)結(jié)果以及糾正行動(dòng)記錄將被存檔保存。
.
.
.
.
結(jié)束...
