好心人，谁能帮忙翻译下吗？

gexianying123

Representative Pre-Inspection FDA Requests

General Firm Information[size=11.0000pt] – [size=11.0000pt]please have the following information in English[size=11.0000pt], both electronically (CD, preferably in MS Word format) and hardcopy, and include a table of contents with a brief description of each file.  When MS Word format is not feasible, then Adobe Acrobat is acceptable; make sure the Adobe file is “searchable.”  This is not an all-inclusive list, so other matters may be covered, addressed, and/or requested during inspection, as needed.  
[size=11.0000pt]- [size=11.0000pt]have someone keep track of people who participate in the inspection with name, title, date, and subject matter discussed, and provide this information (hardcopy) at the end of each day[size=11.0000pt];
[size=11.0000pt]- [size=11.0000pt]at start of inspection, provide information to include:  
[size=11.0000pt]o [size=11.0000pt]firm overview including physical location and mailing addresses, updated firm name, FEI #, office/fax phone numbers, website, key contact person(s);
[size=11.0000pt]o [size=11.0000pt]facility’s US Agent name and full contact information (cannot[size=11.0000pt] be a PO Box address; include email and company’s website, if applicable);
[size=11.0000pt]o [size=11.0000pt]narrative description of history of business, incorporation date and city, public or private, corporate structure, name changes, any significant events/milestones, when commercial manufacturing started, and the dates of any significant additions or renovations;
[size=11.0000pt]o [size=11.0000pt]address and FEI# of any other locations for your company, general type of operations that occur at each location, and whether products are manufactured/intended for the US.  Please use the following format[size=11.0000pt]:

Site Name	FEI#	Address	Type of operations	Product for US Market
[size=9.0000pt]Lake Site	[size=9.0000pt]3000123456	[size=9.0000pt]1586 Lake Road, Madison, WI 10021, USA	[size=9.0000pt]finished dosage tablets, HQ	[size=9.0000pt]Yes
[size=9.0000pt]River Site	[size=9.0000pt]3000123457	[size=9.0000pt]1342 River Road, Madison, WI 10028, USA	[size=9.0000pt]control laboratory	[size=9.0000pt]No
[size=9.0000pt]China Site	[size=9.0000pt]3000123458	[size=9.0000pt]89 Hachen Road, Yanti Development Area, District, City, Province, CN	[size=9.0000pt]non-sterile API, non-pharmaceutical chemicals	[size=9.0000pt]Yes

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[size=11.0000pt]o [size=11.0000pt]firm’s president name and complete contact information; if applicable, Board of Directors names, titles, and complete contact information;
[size=11.0000pt]o [size=11.0000pt]name and complete contact information of the person onsite to whom FDA correspondence should be addressed;
[size=11.0000pt]o [size=11.0000pt]annual sales of the firm, annual sales US market, % product shipped to the US (directly or indirectly[size=11.0000pt]);
[size=11.0000pt]o [size=11.0000pt]hours/days of operation and number of shifts;
[size=11.0000pt]o [size=11.0000pt]number of employees; number of employees per group (e.g. QA, Production, QC, Materials); and whether full or temporary;
[size=11.0000pt]o [size=11.0000pt]names of ALL products manufactured at the firm (identify cytotoxic, hormones, and sensitizing products, if any);
[size=11.0000pt]o [size=11.0000pt]narrative description of the firm’s operations (e.g. type of products manufactured, whether release, stability and/or micro testing are conducted, whether labeling and packaging; whether products are under contract or private own label);
[size=11.0000pt]o [size=11.0000pt]facility description/layout (provide diagrams and square footage of each major area and entire site; include materials and personnel flow and air classifications of production areas); and
[size=11.0000pt]o [size=11.0000pt]manufacturing process diagrams (identify all sampling, major equipment, and critical process parameters and critical quality attributes[size=11.0000pt]);
[size=11.0000pt]- [size=11.0000pt]provide copy of most current FDA drug registration that includes a list of ALL drugs which are being manufactured, prepared, propagated, compounded, or processed by the firm, as stated in the registration;
[size=11.0000pt]- [size=11.0000pt]firm’s organizational charts with names and titles; also include a corporate organizational chart, if applicable.  Please write out the name and title of each person[size=11.0000pt] in the organizational charts;
[size=11.0000pt]- [size=11.0000pt]narrative description of key personnel with brief job description, responsibilities, and CV; please use the following format[size=11.0000pt]:

Name	Job Title	Duties	Reports to
[size=10.0000pt]John Smith	[size=10.0000pt]President	[size=10.0000pt]All employees ultimately report to Mr. Smith.  Responsible for hiring or firing managers.  Approves capital expenditures.  Hired on 2/14/2000; at the current position since 2/14/2009.	[size=10.0000pt]Board of Directors
[size=10.0000pt]Mary Johnson	[size=10.0000pt]QC Manager	[size=10.0000pt]Supervises all analysts of the quality control lab.  Responsible for review and approval of analytical data and procedures.  Reports to the President.  Hired on 2/14/2005; at the current position since 2/14/2012.	[size=10.0000pt]President

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[size=11.0000pt]- [size=11.0000pt]list of all batches manufactured (for the past 3 years if this is an initial inspection) or batches you have shipped or intent to ship directly or indirectly[size=11.0000pt] to the US since the last FDA inspection.  Identify status (e.g. approved, rejected, quarantine), and batch type (e.g. commercial, validation, stability, rework, and/or reprocess).  Please use the following format[size=11.0000pt]:

Product Name	Batch #	Amount shipped	Date of manufacture	Date of shipment	Consignee	Comments, batch status and type
[size=8.0000pt]Product 1	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]validation & stability
[size=8.0000pt]Product 2	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]rejected; deviation 201401-01
[size=8.0000pt]Product 3	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]	[size=8.0000pt]quarantine; under investigation OOS-201301-01

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[size=11.0000pt]- [size=11.0000pt]For the finished drug products[size=11.0000pt] you have manufactured or any product you intend to manufacture in the future, for the US market[size=11.0000pt], please provide a list in the following format[size=11.0000pt]:

Product Name (API used)	Dosage Form	Strength	Filing type/#, sponsor & address	Date of first commercial batch	Date of most recent commercial batch	Clinical Indication
[size=8.0000pt]Product Name	[size=9.0000pt]Powder for Injection	[size=9.0000pt]	[size=9.0000pt]Prescription product	[size=9.0000pt]	[size=9.0000pt]	[size=8.0000pt]

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[size=11.0000pt]- [size=11.0000pt]provide the anticipated production and laboratory schedules for the week of the inspection.
[size=11.0000pt]- [size=11.0000pt]list of SOPs for GMP systems (quality, production, laboratory control, facilities and equipment, materials, and packaging & labeling);
[size=11.0000pt]- [size=11.0000pt]list of production and laboratory ancillary systems and equipment/instruments;
[size=11.0000pt]- [size=11.0000pt]annual product quality reviews for APIs and drug products;
[size=11.0000pt]- [size=11.0000pt]complaints received since last inspection; be prepared to discuss each complaint with its corresponding conclusion and corrective action;
[size=11.0000pt]- [size=11.0000pt]recalls conducted;
[size=11.0000pt]- [size=11.0000pt]for finished dosage products:  field alerts since the last inspection;
[size=11.0000pt]- detailed[size=11.0000pt] description of sampling of materials/components, in-process, stability and finished products;
[size=11.0000pt]- [size=11.0000pt]summary narrative description of the qualification of raw materials for acceptance/rejection;
[size=11.0000pt]- [size=11.0000pt]summary narrative description of the reserve sample program;
[size=11.0000pt]- [size=11.0000pt]summary narrative of environmental monitoring (EM) program including frequency of monitoring, sampling type and locations, limits/criteria, and layout with classification of each room; be prepared to discuss last 2 years of EM data;
[size=11.0000pt]- [size=11.0000pt]summary narrative description of the water system (including a description of the water treatment and monitoring program; tests conducted; alert/action limits or acceptance criteria; all filters by type, size, and purpose; maintenance/cleaning/ sanitizing schedule) use to process water for the manufacture of US products; be prepared to discuss last 2 years of test data;
[size=11.0000pt]- [size=11.0000pt]record of manufacturing deviations/investigation since previous inspection; be prepared to discuss in detail;
[size=11.0000pt]- [size=11.0000pt]record of OOS investigations, non-conformances, deviations, incidents or whatever you call it since previous inspection; be prepared to discuss in detail;
[size=11.0000pt]- [size=11.0000pt]record of changes (change control) since previous inspection; identify according to significance (e.g. critical, major, moderate, minor); changes in personnel, test methods, manufacturing process, packaging, equipment, and facility;
[size=11.0000pt]- [size=11.0000pt]record of all finished products batches you manufactured (i.e., APIs, intermediates, and drug products) that had to be rejected since the last inspection (include name, exp. date, reason for rejection, and current disposition/location of the material);
[size=11.0000pt]- [size=11.0000pt]record of all finished products that were returned since the last inspection (include name of materials, consignee and address, exp. date, reason for return, and current disposition/location of the material);
[size=11.0000pt]- [size=11.0000pt]list of all suppliers of critical[size=11.0000pt] APIs or components that are used in the manufacture of US products (include name of materials, supplier with address, expiry or retest date);
[size=11.0000pt]- [size=11.0000pt]summary narrative description concerning use of wooden pallets; how are they handled and treated;
[size=11.0000pt]- [size=11.0000pt]summary narrative description of firm’s internal audit program;
[size=11.0000pt]- [size=11.0000pt]summary narrative description of firm’s external audit program for raw materials, APIs, and components;
[size=11.0000pt]- [size=11.0000pt]list of products in stability with batch numbers, number of samples per batch, orientation, stability storage conditions, and purpose of the study (e.g. annual study, validation, deviations or changes);
[size=11.0000pt]- [size=11.0000pt]copy of API and/or finished drug product labeling;
[size=11.0000pt]- [size=11.0000pt]be ready to provide quality agreements between the contractor (e.g. drug applicant) and contracted organization (i.e., contract manufacturer/lab/packager);
[size=11.0000pt]- [size=11.0000pt]list of contractors providing GMP support/services (name, contact information, and purpose/business of contractors);
[size=11.0000pt]- [size=11.0000pt]list of non-pharmaceutical, regulated products for the US (e.g. foods, flavorings, cosmetics, nutritional supplement ingredients, dietary supplements, or medical devices), if applicable;
[size=11.0000pt]- [size=11.0000pt]list of non-regulated products manufactured or processed by the firm (e.g. industrial chemicals)

JJX

FDA要查你了,这是检察官的问卷，要你提供资料，抓紧了。

皇后

楼主真的一点英语都不懂吗？用翻译软件基本都可以查明白

gexianying123

您好，自己也会翻译，就是想跟各位大师对比一下看有没有翻译不对的地方，论坛确实有很多帮助的资料，最近也在看。。。

wq强仔

反正我是看不明白  呵呵呵呵

cnosema

gexianying123 发表于 2016-4-23 18:00
您好，自己也会翻译，就是想跟各位大师对比一下看有没有翻译不对的地方，论坛确实有很多帮助的资料，最近也 ...

这么多的内容，不太可能有人帮忙全翻译出来的。如果想具体问哪几条，应该指出来。

2A2MXnrNlF

gexianying123 发表于 2016-4-23 18:00
您好，自己也会翻译，就是想跟各位大师对比一下看有没有翻译不对的地方，论坛确实有很多帮助的资料，最近也 ...

拿出你翻译的草稿让大家幇你修改、今天可搞定。

gexianying123

请问QBD在国内外生产上的应用都有哪些？

chen5385973

内容太多了亲 自己找些在线翻译协助下吧