药品生产企业s管理办法

Good Manufacturing Practice for Pharmaceutical Products(Amended in 2010) SDA Order #79Order by Ministry of Health of the People’s Republic of ChinaPublished on February 12, 2011No. 79Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) has passed by Affairs Meeting o n October 19, 2010. This Regulation is now published and shall be effective from March 1, 2011.Director Zhu CHENJanuary 17, 2011Chapter 1 General ProvisionsArticle 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the People’s Republic of China” and “The Regulation on the Implementation of D rug Administration Law of the People’s Republic of China”.Article 2 A pharmaceutical enterprise shall establish pharmaceutical goods’ quality control system. The system shall contain all factors which may affect the quality of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods’ quality in accordance with intending purpose.Article 3 This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products. This Regulation aims to reduce the risks in pharmaceutical goods’ manufacturing process at its maximum,such as pollution, cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements.Article 4 The enterprise shall obey this Regulation strictly,insist on honesty and keep faith,prohibit any ostensible and spurious activities.Chapter 2 Quality ControlSection 1 PrincipleArticle 5 The enterprise shall establish quality targe t in accordance with pharmaceutical goods’ quality control requirements,carry out all requirements related to safety, effective and quality control into the process of phar maceutical goods’ manufacturing, control and products’discharging, storage, delivering, ensure all pharmaceutical goods are produced in accordance with intending purpose and registered requirements.Article 6 Senior administrator in enterprise shall ensure the achievement of intending quality target. Personnel in different levels and provider, dealer shall participate in and take each responsibility.Article 7 The enterprise shall equip adequate personnel, workshop, establishment and equipment in accordance with requirements, and provide essential condition for achieving quality target.Section 2 Quality GuaranteeArticle 8 Quality guarantee is a part of quality control system.The enterprise must establish quality guarantee system, and establish integrate document system at the same time, in order to ensure the system’s effective running.Article 9 Quality guarantee system shall ensure the following:I. Represent the requirements of this Regulation in pharmaceutical goods’design and development.II. In accordance with the requirements of this Regulation in manufacturing management and quality control activities;III. Specific management responsibility;IV. Exact stocked and used raw material and wrapper;V. Effective control in semifinished product;VI. Implement of confirmation and validation;VII. Manufacture, examine, inspect and double examined according to rules strictly;VIII. Each batch of products shall only discharge after quality authorizing person’s approval;IX. Applicable measures to ensure pharmaceutical goods’quality during the process of storage, delivering and all succedent operation process;X. According to self-examine rules, examine and evaluate the validity and applicability of the quality guarantee system quality.Article 10 Basic requirements of pharmaceutical goods’ manufacture quality management:I. Frame manufacturing technique, systemic review and demonstrate it couldcontinuous stably manufacturing products in accordance with requirements;II. Manufacturing technique and its important changes shall be validated; III. Equip all required resources, include, but not limited the following:1. Hold applicable qualification and the eligible trained personnel;2. Adequate workshop and space;3. Applicable equipment and maintain guarantee;4. Accurate raw material, wrapper and label;5. Approved technique rules and operate rules;6. Applicable storage and freight condition.IV. Use accurate and easy understand language to frame operate rules;V. The operate person could accurate operate according to operate rules after training;VI. The whole manufacture process shall be recorded. The windage shall be researched and be recorded;VII. Batch record and delivering record shall be traced back to the whole history of the batch of products, and the records shall be saved appropriately and be easy consult;VIII. Reduce the quality risk during the pharmaceutical goods’ delivering process;IX. Establish pharmaceutical goods’ recall system, and ensure any batch delivered and sold products could be recalled;X. Survey the reasons leading to pharmaceutical goods’complaints and quality objections, take measures to prevent similar quality objections.Section 3 Quality ControlArticle 11 Quality control includes corresponding organization, document system and sampling, test and so on, to ensure material or products finish necessary examination before delivering, and to verify its quality is in accordance with the requirements.Article 12 Basic requirements of quality control:I. Equip applicable establishment, equipment, instrument and trained personnel to effective and reliable finish all related quality control activities;II. Have approved operate rules, which used to sampling, examine, inspect raw material, wrapper, semifinished product, bulk product and finished product and products’ stability, monitor environment when necessary, to ensure the products is in accordance with the requirements of this Regulation;III. Authorized person shall sampling to raw material, wrapper, semifinished product, bulk product and finished product according to stated methods;IV. Inspect methods shall be confirmed and validated;V. Sampling, check, inspect shall be recorded, the windage shall be researched and be recorded;VI. Material, semifinished product, bulk product and finished product shall be checked and inspected according to quality standard and be recorded;VII. Material and packaged finished product shall have enough reserved samples so that necessary check or inspect shall be taken; except the finished product with too large package container, the reserved sample s’package shall be the same with the final package of the finished product.Section 4 Quality Risk ManagementArticle 13 Quality risk management is evaluate, control, communicate, audit system process to quality risk during the whole product life period, via the manner of foresee or review.Article 14 Quality risk shall evaluate according to science knowledge and experience in order to ensure products’ quality.Article 15 The method, measure, form take during the quality risk management process and the documents formed in the said process shall accommodate to the level of the existent risk.Chapter 3 Organization and PersonnelSection 1 PrincipleArticle 16 An enterprise shall establish management organization which accommodate to the pharmaceutical goods’ product and have its organization framework chart.The enterprise shall set up independent quality management department, which carries out the responsibilities of quality guarantee and quality control. The quality management department could set up quality guarantee department and quality control department respectively.Article 17 Quality management department shall take part in all activities relating to quality, and take responsibility to audit all documents relating to this Regulation. The personnel in quality management department shall not relegate his responsibility to the personnel in other department.Article 18 The enterprise shall be staffed by an appropriate number of management and technical personnel with appropriate qualification (including education background, training and practice experience), and the responsibilities of each department and each station shall be clarified. Station’s responsibility shall not be missed and cross responsibility shall be prescribed specifically. Responsibility taken by each person shall not be overfull.Every person shall clear and understand his own responsibilities, be familiar with the requirements related to his responsibilities, and accept necessary training, including pre-job training and on-job training.Article 19 Generally, one shall not relegate his responsibility to other person. If the responsibilities do need to be relegated, the one should relegate his responsibility to the designated person who has equivalent qualification.Section 2 Important PersonArticle 20 The important person shall be the full-time person of the enterprise, at least including the director of the enterprise, director of manufacturing management, director of and authorized person of quality. Director of quality management and director of manufacturing management shall be independent of each other. Director of quality management and authorized person of quality shall not be independent of each other.Operation proceduress shall be established so that authorized person of quality could take his responsibility independently, with no interference from director of enterprise and other person.Article 21 Director of enterpriseDirector of enterprise is the main responsible person of pharmaceutical goods’quality, who comprehensive responsible to the daily management of the enterprise. In order to ensure the enterprise complete quality target and manufacture pharmaceutical goods according to this Regulation, the director of enterprise shall take responsible for providing necessary resources, reasonable plan, organize and correspond to ensure the quality management department could take its responsibility independently.Article 22 Director of manufacturing managementI. Qualification:Director of manufacturing management shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least three years’pharmaceutical goods’manufacturing and quality management experience, including at least one year’s pharmaceutical goods’manufacturing management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1. Manufacture and storage the pharmaceutical goods according to approvedtechnology procedure in order to ensure the quality of the pharmaceutical goods;2. Ensure every operation proceduress related to manufacturing operationare performed strictly;3. Ensure batch production record and batch package record are audited bydesignated person and submitted to quality management department;4. Ensure the maintenance of workshop and equipment in order to preserveits good working condition;5. Ensure all kind of necessary validation work is completed;6. Ensure person related to manufacturing have been trained by pre-jobtraining and on-job training, adjust training content according to actual demands.Article 23 Director of quality managementI. Qualification:Director of quality management shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least five years’pharmaceutical goods’manufacturing and quality management experience, including at least one year’s pharmaceutical goods’quality management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1. Ensure the raw material, wrapper, semifinished product, bulk product andfinished product are in accordance with the registered approved requirements and quality standard;2. Ensure the products are audited to batch record before delivering;3. Ensure necessary inspection is finished;4. Approve quality standard, sampling method, inspection method and otheroperation proceduress of quality management;5. Audit and approve all changes related to quality;6. Ensure all important windage and exceed criterion inspection results havebeen researched and been dealt with in time;7. Approve and supervise consigned inspection;8. Supervise the maintenance of workshop and equipment in order to maintainits good working condition;9. Ensure to finish every necessary confirmation and validation work,checking and approving confirmation or validation scheme and report;10. Ensure to finish self-check;11. Evaluate and approve material supplier;12. Ensure all complaints related to product quality have been researched,and have been dealt with in time and accurately;13. Ensure to finish products’persistent stability review plan, providethe data of persistent stability review;14. Ensure to finish product quality review analysis;15. Ensure quality control and quality guarantee person have been trainedby pre-job training and on-job training, adjust training content according to actual demands.Article 24 Director of manufacturing management and director of quality management often have the following common responsibility:I. Audit and approve the documents of products’ technology procedure, operation proceduress;II. Supervise the sanitation condition of factory;III. Ensure the key equipment have been confirmed;IV. Ensure to finish the validation of production technology;V. Ensure all related person in enterprise been trained by pre-job training and on-job training, adjust training content according to actual demands; VI. Approve and supervise consigned manufacture;VII. Ensure and monitor the storage condition of material and goods; VIII. Save the record;IX. Supervise the implement condition of this Regulation;X. Monitor the factors influence the quality of the products.Article 25 Authorized person of qualityI. Qualification:Authorized person of quality shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least five years’pharmaceutical goods’manufacturing and quality management experience, have the experience of manufacturing process control and quality check work. Authorized person of quality shall have necessary professional theory knowledge, have taken part in the train about product delivering, and could take his responsibility independently.II. Main responsibility:1. Take part in the establishment of enterprise quality system, interiorself-check, exterior quality audit, validate and pharmaceutical goods’bad reaction report, product recall and other quality management activities;2. Take the responsibility of product delivering, to ensure themanufacturing, checking of every batch of delivered products are all in accordance with corresponding code, pharmaceutical goods’ registered requirements and quality standard;3. Before delivering the products, authorized person of quality must issueproduct delivering audit record according to the said item 2 and bring it into batch record.Section 3 TrainingArticle 26 The enterprise shall designate department or person to take responsible for training management work, and shall have the training scheme or plan audited or approved by director of manufacture management or director of quality management. The training record shall be preserved.Article 27 All personnel related to pharmaceutical goods’manufacturing, quality shall be trained, the training content shall accommodate to the post. Except the training of theory and practice of this Regulation, responsibility, skill training about the related code,relevant post shall also be trained, and actual effect shall be periodic evaluated.Article 28 The working person in high risk operating area (such as: manufacture area of high activity, high toxic, infective, high sensitive material) shall take expert training.Section 4 Personnel SanitationArticle 29 All personnel shall take sanitation requirements training, the enterprise shall establish personnel sanitation operation proceduress,so that to reduce the pollution risk to pharmaceutical goods taken by person at its maximum.Article 30 Personnel sanitation operation procedures shall include the content related to health, sanitation practice and personnel dress. Personnel in manufacturing area and quality control area shall correctly understand related personnel sanitation operation procedures. The enterprise shall take measures to ensure the implement of personnel sanitation operation procedures.Article 31 The enterprise shall manage personnel’s health and establish health file. The manufacture personnel contact pharmaceutical goods directly shall receive physical check, and take at least one physical check per year.Article 32 The enterprise shall take appropriate measure to avoid the person have wound in body surface, have infection disease or other person may pollute pharmaceutical goods to take the manufacture work which directly contact pharmaceutical goods.Article 33 Visiting person and untrained person shall not enter manufacture area and quality control area, if the persons need to enter in special conditions, the items of their individual sanitation, clothes changing and so on shall be instructed.Article 34 Any person enters into manufacturing area shall change clothes according to prescription. The material, style and dressing method of work clothes shall be accommodate to the work engaged and the level of air clean degree.Article 35 The person enters into clean manufacturing area shall not make up and adorn with accouterment.Article 36 Manufacturing area, storage area shall forbid smoking and having meals, forbid to store food, beverage, cigarette and individual pharmaceutical goods and other non-manufacturing goods.Article 37 Operation person shall avoid to touch the surface of pharmaceutical goods, wrapper material contact pharmaceutical goods directly and equipment by hand.Chapter 4 Workshop and EstablishmentSection 1 PrincipleArticle 38 The workshop location’s choice, design, overall arrangement, construct, reconstruct and maintenance must in accordance with the pharmaceutical goods’ manufacturing requirements, which may avoid pollution, cross pollution, confusion and mistake at its maximum, and may convenient for clean, operate and maintenance.Article 39 The workshop’s location shall consider according to the workshop and manufacturing safety measures. The environment of the workshop shall reduce the pollution risk to material or products at its maximum.Article 40 The enterprise shall have tidy manufacturing environment. The floor, road surface of the workshop and transport shall not pollute the pharmaceutical goods’manufacturing. The overall arrangement of the manufacturing area, administration area, living area and assistant area shall be reasonable arranged and do not interfere each other. Stream of people and material in factory area and workshop shall reasonable.Article 41 The workshop shall take appropriate maintenance, and ensure the maintenance activity may not influence the quality of pharmaceutical goods. Clean or take necessary sterilization to workshop according to detailed written operation procedures.Article 42 The workshop shall have appropriate illumination, temperature, humidity and aeration, to ensure the quality of produced and reserved products and the performance of related equipment shall not be influenced directly or indirectly.Article 43 The design and installation of workshop, establishment shall effective prevent insect or other animal to enter in. Necessary measures shall be taken to prevent of using raticide, insecticide, smoke fumigant and so on which may pollute equipment, material, goods.Article 44 Necessary measures shall be taken to prevent unauthorized person to enter in. Manufacturing, storage and quality control area shall not be the direct gate for staffs not in this area.Article 45 Complete drawing of constructed or reconstructed workshop, public service, fixed pipeline shall be saved.Section 2 Manufacturing AreaArticle 46 In order to reduce pollution and cross pollution risk, workshop, manufacturing establishment and equipment shall reasonable designed, overall arranged and used according to the characteristic, technique process and corresponding clean level, and in accordance with the following requirements: I. Comprehensive considering the pharmaceutical goods’ characteristic,technique and intending purpose and other factors, to confirm feasibility of using workshop, manufacturing establishment and equipment together, and hing related evaluating report;II. Special and independent workshop, manufacturing establishment and equipment must be used when manufacturing special character pharmaceutical goods, such as high sensitive pharmaceutical goods (i.e.Penicillin) or biologics goods (i.e. bcg vaccine or other pharmaceutical goods prepared by active microorganism). The operating area with large quantity of dust forpenicillin species pharmaceutical goods shall keep comparatively negative pressure, the exhaust gas discharged to outdoor shall carry cleanse management and make it be up to the mustard. Air outlet shall be away from air inlet of other air cleanse system;III. Special establishment (i.e. independent air cleanse system) and equipment must be used when manufacturing β-lactam structure species pharmaceutical goods, sex hormone species prophylactic pharmaceutical goods, and shall be detached with other pharmaceutical goods’ manufacturing area strictly;IV. Special establishment (i.e. independent air cleanse system) and equipment shall be used when manufacturing some hormone species, cell toxicity species, high active chemical pharmaceutical goods; under special circumstance, if necessary validation shall be take before taking special protection measures, the above said pharmaceutical goods preparation could use the same establishment and equipment via manufacturing modes in different phases;V. Ventilation of air cleanse system in the above said item II, III, IV shall take cleanse management;VI. Pharmaceutical goods’ manufacturing workshop shall no t used for manufacturing non-officinal used products which may have bad influence to pharmaceutical goods’ quality.Article 47 Manufacturing area and storage area shall have enough space to ensure equipment, material, semifinished product, bulk product and finished product could storage in order, to prevent the confusion, cross pollution of different products or material, to prevent missing or mistake during the operation of manufacturing or quality control.Article 48 Air condition cleanse system shall be equipped according to pharmaceutical goods’ variety, manufacturing operation’s requirement and exterior environment condition which let the manufacturing area can effective aeration, and have temperature,humidity control and atmosphere cleanse filtration, to ensure the manufacturing environment of pharmaceutical goods is in accordance with the requirements.The pressure difference between clean area and non-clean area, clean areas in different level shall not lower than 10 Pascal. When necessary, appropriate pressure difference grads shall also be kept in different functional areas (operation area) with same clean level.Exposure working procedure area for oral liquid and solid preparation, chamber use pharmaceutical goods (including rectal pharmaceutical goods), surface external use pharmaceutical goods and other non-asepsis preparation manufacturing and exposure working procedure area for wrapper material directly contact pharmaceutical goods shall equip according to the requirements of “Asepsis Pharmaceutical Goods” D level clean area in Annex. The enterprise could take appropriate microorganism monitor measures according to product s’standard and characteristic.Article 49 Inner surface of clean area (wall, floor, sunshade) shall be slick, non-crack,narrow joint, non granule fell off, prevent stored dust, convenient for effective clean, and take sterilization when necessary.Article 50 The design and installation of every kind of pipeline, lighting establishment, place with a draught and other public establishment shall prevent having the part of not easy to clean, and shall try best to maintain outside the manufacturing area.Article 51 Sewerage shall have appropriate size and install the device of reversing flow. Try best to prevent drain in clear channel, if it is inevitably, the clear channel shall be flat so that it is convenient to clean and sterilize.Article 52 Quantify of preparation’s raw material often carry on in the metage room special designed.Article 53 Operation rooms which produce dust (such as sampling, metage, mix, package of dry material or products rooms and other operation rooms) shall keep comparatively negative pressure or take special measure, so as to prevent the diffusion of powder dust, avoid cross pollution and easy to keep clean.Article 54 Pharmaceutical goods’packaging workshop or area shall be reasonable designed and arranged, to prevent confusion or cross pollution. If there are several packaging lines in one area, isolation measures shall be taken.Article 55 Manufacturing area shall have appropriate light, the light in contact manufacturing area shall satisfy the operation requirements.Article 56 Manufacturing area could set middle control area. However, middle control operation shall not bring quality risk to pharmaceutical goods.Section 3 Storage AreaArticle 57Storage area shall have enough space, which ensure the under-examined, qualified, disqualified, withdrew or recalled raw materia l,wrapper, semifinished product, bulk product and finished product and all kinds of material and products could store in order.Article 58 The design and construct of storage area shall ensure good storage condition, and have aeration and lighting establishment. Storage area shall satisfy material or products’storage condition (such as temperature, humidity, avoid of light) and safety storage requirements, and check and monitor shall be taken.Article 59 High active material or product and printing package material shall storage in safe area.Article 60 Receiving, extending and delivering area shall protect material, product out of influence of weather outside(such as rain, snow). The arrangement and establishment of receiving area shall ensure taking necessary cleaning to the received material’s outside packaging.Article 61 If the under-examined material is stored in separate isolate area, the under-examine area shall have distinct mark, and only authorized person could in and out.Disqualified, withdrew or recalled material or product shall be stored isolated. If other method is used for replacing physics isolation, this method shall have equal security.Article 62 Separate material sampling area is often set up. Air cleaning level of sampling area is the same with the manufacturing requirements. If sample is taken in other area or use other method, pollution or cross pollution shall prevent.Section 4 Quality Control AreaArticle 63 Quality control laboratory is often divided from manufacturing area. Biology examine,microorganism and radioactivity isotope laboratory shall also divided from each other.Article 64 The design of laboratory shall ensure for applying it’s intending purpose, and prevent confusion and cross pollution, enough area shall have for disposing samples, reserved samples and samples for reviewing stability and keeping the records.Article 65 When necessary, set a special instrument room to prevent static, shaking, humid or other outside factors’ disturbance to instrument with high sensitivity.Article 66 The laboratory disposing special goods such as biology samples or radioactivity samples shall in accordance with the related requirements of the country.Article 67 Experiment animal room shall be strictly divided from other area. Its design, construct shall in accordance with the related requirements of the country and have independent air disposing establishment and animal’s special channel.Section 5 Assistant AreaArticle 68 Retiring room shall not take bad influence to manufacturing area, storage area and quality control area.。

药品生产监督管理办法Measures for the Supervision over and Administration ofPharmaceutical Production国家食品药品监督管理总局State Food and Drug Administration药品生产监督管理办法Measures for the Supervision over and Administration of Pharmaceutical Production （2004年8月5日国家食品药品监督管理局令第14号公布根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正）The Measures for the Supervision over and Administration of Pharmaceutical Production, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration, are hereby promulgated, and shall come into force as of the date of promulgation.第一章总则Chapter I General Provisions第一条为加强药品生产的监督管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法》、《药品管理法实施条例》），制定本办法。

Article 1 With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China, Regulation on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, Regulation on the Implementation of the Pharmaceutical Administration Law).第二条药品生产监督管理是指食品药品监督管理部门依法对药品生产条件和生产过程进行审查、许可、监督检查等管理活动。

Understand yourself according to your own meaning, and don't underestimate yourself and be led astray byother people's opinions.简单易用轻享办公（页眉可删）最新《药品流通监督管理办法》全文第一章总则第一条为加强药品监督管理，规范药品流通秩序，保证药品质量，根据《中华人民共和国药品管理法》(以下简称《药品管理法》)、《中华人民共和国药品管理法实施条例》(以下简称《药品管理法实施条例》)和有关法律、法规的规定，制定本办法。

第二条在中华人民共和国境内从事药品购销及监督管理的单位或者个人，应当遵守本办法。

第三条药品生产、经营企业、医疗机构应当对其生产、经营、使用的药品质量负责。

药品生产、经营企业在确保药品质量安全的前提下，应当适应现代药品流通发展方向，进行改革和创新。

第四条药品监督管理部门鼓励个人和组织对药品流通实施社会监督。

对违反本办法的行为，任何个人和组织都有权向药品监督管理部门举报和控告。

第二章药品生产、经营企业购销药品的监督管理第五条药品生产、经营企业对其药品购销行为负责，对其销售人员或设立的办事机构以本企业名义从事的药品购销行为承担法律责任。

第六条药品生产、经营企业应当对其购销人员进行药品相关的法律、法规和专业知识培训，建立培训档案，培训档案中应当记录培训时间、地点、内容及接受培训的人员。

第七条药品生产、经营企业应当加强对药品销售人员的管理，并对其销售行为作出具体规定。

第八条药品生产、经营企业不得在经药品监督管理部门核准的地址以外的场所储存或者现货销售药品。

第九条药品生产企业只能销售本企业生产的药品，不得销售本企业受委托生产的或者他人生产的药品。

第十条药品生产企业、药品批发企业销售药品时，应当提供下列资料：(一)加盖本企业原印章的《药品生产许可证》或《药品经营许可证》和营业执照的复印件;(二)加盖本企业原印章的所销售药品的批准证明文件复印件;(三)销售进口药品的，按照国家有关规定提供相关证明文件。

药品生产公司文件管理制度一、目的本文件管理制度旨在建立和维护一个有序的文件控制体系，确保药品生产和质量控制活动的所有文件都能够被正确编写、审核、批准、分发和维护。

通过这一体系，公司能够确保文件的准确性、完整性和可追溯性，满足法规要求和客户要求。

二、适用范围本制度适用于本公司所有涉及药品生产和质量控制的文件，包括但不限于工艺规程、操作标准、记录表格、检验报告、培训资料等。

所有员工必须遵守本制度的规定，对文件进行妥善管理。

三、责任1. 质量管理部门负责本制度的制定、修订和监督执行。

2. 各部门负责人负责本部门文件的编写、审核和更新。

3. 所有员工负责遵守文件管理规定，确保文件的正确使用和保管。

四、文件分类和编码1. 文件应根据其性质和用途进行分类，如技术文件、质量管理文件、记录文件等。

2. 每个文件应有唯一的编码，以便识别和追溯。

编码规则应简单明了，易于理解。

五、文件编写和审核1. 文件编写应遵循公司规定的格式和内容要求，确保信息的准确性和完整性。

2. 文件编写完成后，应由相关部门负责人进行审核，必要时还应进行专业评审。

3. 审核通过后，文件应由授权人员签字批准，方可正式发布。

六、文件发布和分发1. 经批准的文件应由质量管理部门统一发布，并记录发布日期和版本号。

2. 文件应分发到所有相关部门和使用场所，确保相关人员能够获取最新版本的文件。

七、文件变更和更新1. 文件如有变更需求，应按照文件编写和审核程序进行。

2. 变更后的文件应及时更新版本号，并通知所有持有旧版文件的人员更换新文件。

八、文件存档和保管1. 所有文件应妥善存档，电子文件应备份在安全的服务器上，纸质文件应存放在指定的档案室内。

2. 文件的存档期限应符合法规要求和公司政策，过期文件应按照规定程序销毁。

九、文件访问和复制1. 文件的访问应限制在授权人员范围内，防止未授权的访问和修改。

2. 文件的复制应得到相关部门负责人的批准，并记录复制的日期和数量。

It’s not easy to push me away as a stubborn gangster and become dusty as a diamond.悉心整理助您一臂（页眉可删）药品生产企业需要遵循哪些法律规定？导读：随着我国改革的不断深化，对外开放逐步放大，药品的需求也越来越大，维护人民身体健康和用药的合法权益是《药品管理法》的根本目的，加强药品企业的管理，保证药品质量，从源头控制药品问题，切实做好药品的生产工作，让药品能够真正发挥其有效的作用。

随着我国改革的不断深化，对外开放逐步放大，药品的需求也越来越大，维护人民身体健康和用药的合法权益是《药品管理法》的根本目的，加强药品企业的管理，保证药品质量，从源头控制药品问题，切实做好药品的生产工作，让药品能够真正发挥其有效的作用。

第二章药品生产企业管理第七条开办药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》。

无《药品生产许可证》的，不得生产药品。

《药品生产许可证》应当标明有效期和生产范围，到期重新审查发证。

药品监督管理部门批准开办药品生产企业，除依据本法第八条规定的条件外，还应当符合国家制定的药品行业发展规划和产业政策，防止重复建设。

第八条开办药品生产企业，必须具备以下条件：(一)具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人;(二)具有与其药品生产相适应的厂房、设施和卫生环境;(三)具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备;(四)具有保证药品质量的规章制度。

第九条药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。

药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的，发给认证证书。

《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

药品生产企业授权管理制度一、总则为了加强对药品生产企业的管理，维护药品生产企业的法定权益，促进药品生产企业合法合规经营，保障人民群众用药安全和合理用药，根据《药品生产企业管理规范》和相关法律法规，制定本制度。

二、授权管理的基本要求1. 授权合法合规药品生产企业在授权经营过程中，应严格遵循国家有关药品经营管理的法律法规，确保授权行为合法合规。

2. 授权范围合规药品生产企业应当将授权范围、授权时间、授权内容等明确规定在授权文件中，严格限定授权范围，并确保授权行为符合国家相关规定。

3. 授权机构合规药品生产企业应当选择具备相应资质的授权机构，确保授权机构的正当性和合规性。

4. 授权行为合规药品生产企业应当与授权机构签署书面授权协议，确保授权行为的合法性和合规性。

5. 授权管理规范药品生产企业应当建立健全授权管理的制度和流程，包括授权申请、授权审核、授权监督等环节，确保授权管理工作的规范化和制度化。

三、授权管理的基本程序1. 授权申请药品生产企业需要进行授权经营的，应当向具备相应资质的授权机构提交授权申请，并提供相关资料。

2. 授权审核授权机构应当对药品生产企业提交的授权申请进行审核，核实药品生产企业的资质和合规性，确定是否授予授权。

3. 授权协议签署经审核合格后，授权机构和药品生产企业应当签署书面授权协议，明确授权范围、授权时间、授权内容等。

4. 授权监督授权机构应当对药品生产企业进行授权活动的监督和检查，确保药品生产企业的授权行为合规合法。

四、授权管理的监督检查国家药品监督管理部门对药品生产企业的授权行为进行定期和不定期的监督检查，对发现的违法行为及时处理，确保药品生产企业的授权活动合法合规。

五、授权管理的处罚规定对药品生产企业违反授权管理制度的行为，国家药品监督管理部门会依法采取相应的处罚措施，包括警告、罚款、责令停产整顿等。

六、授权管理的信息公开国家药品监督管理部门将对药品生产企业的授权信息进行公开，提供给社会公众查询，确保授权活动的透明度和公开性。

Page: 1of 6. SOP #A-195-02-0100S T A N D A R D O P E R A T I N GP R O C E D U R E SPROCEDURES FOR HANDLING OOS RESULTS1.PURPOSET he purpose of this Standard Operation Procedure is to establish a procedure for the routine handling of out-of-specification (OOS) laboratory results The investigation or ‘failure investigation’ should where ever possible identify the cause of the OOS and evaluate its impact.2.RESPONSIBILITYE ach Analyst or Researcher is responsible for the immediate analytical review of OOS results in cooperation with the laboratory head of supervisor/delegate. All solutions and standards must be preserved and properly stored.The laboratory head of supervisor is responsible for the final decision as to the disposition and use of the result.3.FREQUENCYI mmediately afterwards (where possible) or within 1 to 2 days of each completed analytical test (after being checked, audited and reviewed by the supervisor).4.PROCEDURE[a]. A nalysts may classify Out-of-Specification Test Results (OOS) as reversible or as non-reversible due to either a :-Ügenuine laboratory error orÜsampling errorNon-reversible classification may cover:-Ümanufacturing or processing errors (including manufacturing operator error) [b.] I nvestigation for Genuine Laboratory An alytical Error.A nalysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. Check if samples were incorrectly prepared, diluted, injected or stored at inappropriate environmental temperatures or that containers not properly closed or possibly not sampled in the correct designated sampling container. [e.] S uspected laboratory error must be investigated and if a genuine error is found, then the OOS result must immediately be invalidated. The OOS result must be disregarded (after appropriate recording and filing).[c].E ach Analyst shall review for completeness the entire test procedure, equipment / calibration and calculation used in obtaining the test result using the attached guideline checklists.Edition Number:Effective Date:APPROVEDPROCEDURES FOR HANDLING OOS RESULTSPage: 2of 6 [d].T he supervisor shall review and discuss in depth with the analyst, theexecution of the entire analytical testing procedure, equipment and calculation used.[e.] O nce the nature of the OOS has been identified - as an laboratory error - a repeat test must be performed and the initial test totally discarded as a reversible laboratory error. (since the initial test result was proven invalid)[f.] T he analytical or analyst error must be thoroughly documented and properly invalidated - with written reasons, together with the supervisor and analyst signatures and date of the invalidation process.INCONCLUSIVE ERRORS RETEST[g.] A n inconclusive error is an OOS where the 'supervisor-analyst investigation' did not draw a firm conclusion and the reason for the error was not clearly identified.[h.] R etest with new aliquot (replicates, if required) from the same sample, if the sampling procedure was proven OK by investigation.[i.] I f the sampling procedure is found to be in error, then re-sample the target material is undertaken and a new duplicate analysis is performed.DECISION TREE5.LIMITATION[j.] A n overview of Out-of-Specification Results procedures is provided by a decision tree flowchart. The decision tree provides a logical set of procedural steps in order to standardize the investigative procedure for all analysts when performing an OOS investigation.[f.] R e-sampling the material for a new representative sample should take place only when the original procedure was found to be clearly non-representative of the whole.6.DOCUMENTATION[k.] Out-of-specification (OOS) Test Results Report or ‘failure investigation Test Result Report’ is prepared and filed.3[End of Document]•‚ƒ„…†‡Œ•ŽEdition Number:Effective Date:APPROVEDEdition Number:Effective Date:APPROVED ØC H E C K L I S T ×SOP # A -195-02-0100OUT-of-SPECIFICATION RESULTS‘…A v e r a g i n g p a s s i n g a n d O O S T e s t R e s u l t s t o g e t h e ri s n o t p e r m i t t e d a s i t c o n c e a l s t h e f u l l a n a l y t i c a l p i c t u r e …’IDENTIFYING OOS TEST RESULTS1. Does the firms have a clear SOP spelling out the procedure and investigations required when ever an OOS result is obtained?q Yes q No 2. Are all firm's 'rejected batch' OOS results investigated as well?q Yes q No 3. Are the previous (or related) batches associated with the failed batch specification reviewed and the overall impact (on quality) evaluated?q Yes q No 4. Are written investigations undertaken and then follow-up procedures recommended in writing?q Yes q No 5. Are the investigations performed in a timely manner and follow a defensible scientific logic (see attached Decision Tree)?q Yes q No 6. Does the companies 'Investigation SOP' include the three key tenants i.e.TO INVESTIGATE - TO CONCLUDE - TO FOLLOW-UP?q Yes q No 7. Have the laboratory analysts been instructed to keep the original 'suspect test solutions' for possible reanalysis (Ref. Decision Tree)?q Yes q No 8. When an OOS has been detected does the initial review, before the investigation, check for instrument or system suitability malfunction, faulty reagents, calculation, documentation or transcribing errors?q Yes q No 9. If no clear analytical errors are detected in a 'suspect result' does a comprehensive 'failure investigation' ALWAYS follow?q Yes q No 10. Where malfunctions are identified and detected are all prior 'suspect data'evaluated and reviewed for a possible related (or similar) errors?q Yes q No 11. Are analytical failures tracked back to their original point of failure?q Yes q No 12. When a faulty lab procedure is detected, is the analytical test procedure immediately terminated (as a matter of routine)?q Yes q No 13. Have the analysts been trained to immediately report to their supervisors an obvious error or an analytical fault?q Yes q No 14. Are obvious errors (spilling, incorrect dilution, injection volume etc.)documented in the lab book and a brand new test restarted?q Yes q NoPage: 3 of 6Edition Number:Effective Date:APPROVED SOP # A -195-02-0100OUT-of-SPECIFICATION RESULTS‘…f a i l u r e i n v e s t i g a t i o n s a r e c o n d u c t e d t o d e t e r m i n ew h a t c a u s e d t h e u n e x p e c t e d O O S r e s u l t …’INVESTIGATING OOS TEST RESULTS15. Does the supervisor's 'initial assessment' follow a written in-house 'SOP procedure '?q Yes q No16. Are the retained 'suspect' sample preparations examined during the 'initialassessment' and then retested promptly on initiating the 'failure investigation'?q Yes q No 17. Where a clear error is identified, is the result immediately invalidated?q Yes q No 18.Where clear error is NOT identified, is a failure investigation conducted immediately?q Yes q No 19. Is the firm's full scale failure investigation fully predefined in writing?q Yes q No 20. Does the firm's own QC Unit perform the 'full scale failure investigation'?q Yes q No 21. Does the general review include a list of related batches which may be impacted?q Yes q No 22. Does the full scale failure investigation include the production side and the laboratory side?q Yes q No 23. Does the laboratory protocol include the two key steps - retesting the original sample and testing a new sample from the batch lot?q Yes q No 24. Retesting the original sample with a new analyst, is generally the first step after the 'initial assessment' is completed?q Yes q No 25. Are the number of re-tests (usually duplicates) specified and not exceeded? Averaging 'original suspect' and retest results is forbidden.q Yes q No 26. When improperly prepared samples are proven as faulty, then the original test results may be immediately invalidated?q Yes q No 27. The firm may re-sample when the investigation highlights that the original sample was unrepresentative?q Yes q No 28. Where the investigation concludes that the sampling method is in error a new sampling method must be developed and qualified?q Yes q No 29. To prove the original aliquot is faulty, the analyst prepares two additional aliquots and compares the three sets of results?q Yes q NoPage: 4 of 6Edition Number:Effective Date:APPROVED SOP # A -195-02-0100OUT-of-SPECIFICATION RESULTS ‘…B a t c h e s m u s t b e f o r m u l a t e d w i t h t h e i n t e n t t o p r o v i d e 100%o f t h e l a b e l e d a m o u n t …'AVERAGING IN OOS RESULTS30. Averaging results from a standard solution or a test aliquot is acceptable (i.e. averaging replicate results).q Yes q No31. Averaging results from microbial count plates are quite acceptable.q Yes q No32. Averaging a set of results, where some are OOS is not acceptable.q Yes q No33. Hiding an OOS result in any average is not acceptable.q Yes q No34. When the intent is to highlight variability within the product then averagingisnot acceptable, but RSD (CV) values are generally reported to show statistical significance.q Yes q No 35. Replicate peak responses whether test or standard should be averages as one result.q Yes q No 36. Are analysts trained, so not to average passing and OOS results together in order to hide the failing results?q Yes q No 37. Composite assays, require only one assay result and are in fact average assay values, as opposed to individual content uniformity values.q Yes q No 38.OUTLIER USE IN OOS RESULTS39. Where 'control' and 'specification' lower and upper limits are used in QC criteria an OUTLIER may be outside the control limits but inside the specifications limits? [i.e. an example of OUTLIER use.]q Yes q No 40. Analyst are trained not to assume OUTLIERS as testing errors but inherent variability in the sample.q Yes q No 41. The firm has an OUTLIERS SOP detailing the use of OUTLIER TESTS.q Yes q No 42. OUTLIERS are not permissible in Content Uniformity and Dissolution tests.q Yes q No 43. Where the intent is to measure the variability, OUTLIERS should not be used.q Yes q NoPage: 5 of 6DECISIONTREE . (IJGD Vol. 02 #07 1998)。

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药品生产监督管理办法（中英文）药品生产监督管理办法Measures for the Supervision over and Administration ofPharmaceutical Production国家食品药品监督管理总局State Food and Drug Administration药品生产监督管理办法Measures for the Supervision over and Administration of Pharmaceutical Production （2004年8月5日国家食品药品监督管理局令第14号公布根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正）The Measures for the Supervision over and Administration of Pharmaceutical Production, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration, are hereby promulgated, and shall come into force as of the date of promulgation.第一章总则Chapter I General Provisions第一条为加强药品生产的监督管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法》、《药品管理法实施条例》），制定本办法。

Article 1 With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China, Regulation on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, Regulation on theImplementation of the Pharmaceutical Administration Law).第二条药品生产监督管理是指食品药品监督管理部门依法对药品生产条件和生产过程进行审查、许可、监督检查等管理活动。

2020年3月30日发布《药场监督管理总局令第27号2020年7月1日起执行质管部 -- 钟海娇 2020年11月药品注册证书载明药品上市许可持有人申请人取得药品注册证书后，为药品上市许可持有人药品再注册发给药品再注册批准通知书药品注册发给药品注册证书，有效期5年药品注册药品批准文号、持有人、生产企业等信息。

非处方药的药品注册证书还应当注明非处方药类别2020年3月30日发布《药品注册管理办法》国家市场监督管理总局令第27号2020年7月1日起执行国药准字H（Z、S）C＋4位年号＋4位顺序号国药准字H（Z、S）＋4位年号＋4位顺序号国药准字H（Z、S）J ＋4位年号＋4位顺序号H代表化学药Z代表中药S代表生物制品境内生产药品境外生产的药品港澳台生产的药品其中批准文号格式2020年3月30日发布《药品注册管理办法》国家市场监督管理总局令第27号2020年7月1日起执行补充申请方式的变更药品生产过程中的重大变更；药品说明书中涉及有效性内容以及增加安全性风险的其他内容的变更持有人转让药品上市许可；国家药品监督管理局规定需要审批的其他变更01020304备案方式的变更01药品生产过程中的中等变更02药品分包装03药品包装标签内容的变更04国家药品监督管理局规定需要备案的其他变更境外生产药品发生上述变更的，应当在变更实施前报药品审评中心备案。

2020年12月1日前生产的药品可以继续使用已印制的现有版本的说明书和标签新药法实施前批准的药品，上市许可持有人应当按照有关规定更新说明书和标签中上市许可持有人的相关信息，境内药品在上市许可持有人所在地省级药品监督管理部门备案，境外药品在药品审评中心备案已上市销售药品的说明书和标签可以在药品有效期内继续使用。

国家药品监督管理局对说明书和标签修订另有要求除外药品包装标签情况药品管理法第四十九条 标签或者说明书应当注明上市许可持有人及其地址2020年3月31日国家药监局发布关于实施《药品注册管理办法》有关事宜的公告广东省药品监督管理局办公室2020年3月11日如持有人与药品生产企业为同一主体的，由持有人自行修订药品说明书和标签的上述内容，无需向省药监局提交备案申请上海市药品监督管理局2020年4月21日湖北省药品监督管理局2020年4月22日如持有人与药品生产企业为同一主体的，由持有人自行修订药品说明书和标签的上述内容。

GSP管理规范GSP应知应会第一部分（全员掌握）1、什么是GSP？新修订的GSP是什么时候颁布施行的？新修订的GSP在批发企业的内容中主要有那些章节？GSP就是药品经营质量管理规范。

新修订的GSP于2013年6月1日正式施行，共187条，其中批发的质量管理122条。

在批发企业的内容中主要有总则、质量管理体系、组织机构与质量管理职责、人员与培训、质量管理体系文件、设施与设备、校准与验证、计算机系统、采购、收货与验收、储存与养护、销售、出库、运输与配送、售后管理。

2、GSP是由规范与附录组成，目前国家药监局颁布的那几个附录？2013年10月23日国家药监局颁布了五个附录：冷藏、冷冻药品的储存与运输管理药品经营企业计算机系统温湿度自动监测药品收货与验收验证管理4、公司的质量方针是什么？由谁颁布实施？质量目标是什么？公司的质量方针由公司最高管理者（程波）颁布实施。

质量方针是：“放心的商品，满意的服务”公司总的质量目标是：1. 顾客满意度≥90％，今后每年递增1％;2.采购药品合格率100%.3. 产品安全交付合格率达98%5、公司质量体系的关键要素有哪些？包括组织机构、人员、设施设备、质量管理体系文件及相应的计算机系统等。

6、公司药品质量的主要责任人是谁？企业负责人（程波）为药品质量的主要责任人，负责提供必要的条件，确保实现公司质量目标。

7、公司内部由谁全面负责药品质量管理工作，行使质量裁决权？质管副总经理（吴彬）全面负责药品质量管理工作，行使质量裁决权。

8、兰州九州通有多少个部门？共有15个部门。

分别是采购部、商业销售部、终端销售部、医院事业部、医疗器械部、基药与处方药事业部、中药部、质管部、企管部、信息部、财务部、行政部、仓储部、运输部、配送部。

9. 公司的质量管理机构是什么，主要有哪些岗位和人员？公司的质量管理机构是质量管理部，人员有质管部长陈惠芸，质管员柴婷婷，验收员何莉红、梁永芳，中药验收员范拯秦，药检报告单管理员徐平，养护员洪翠妙（负责药品的日常检查养护、负责库房药品的存储及温湿度的监测与调控），中药养护员张飞龙，退货员马院平、裴小霞。

一车间6S管理实施方案6S是企业现场管理的根底，通过开展整理、整顿、清扫、清洁、素养、平安活动使员工养成良好的习惯，保持环境和设备整洁，创造一个舒适的工作场所，塑造企业的良好形象，特制定本方案。

一、目的本方案明确了公司6S活动的方法，旨在通过6S活动改善现场不良现象，创造一个干净、整洁，井然有序的工作环境，以降低资源浪费，提高工作效率，提升员工真、善、美的品质，树立公司良好的形象。

二、适用范围本方案使用于本公司全体员工。

三、6S的定义及目的1．因日文罗马家中的整理〔SEIRI〕、整顿〔SEITON〕、清扫〔SEISO〕、清洁〔SEIKETSU〕、素养〔SHITSUKE〕的首个字母都是S，因此被称为5S，随着人们对5S活动认识的不断深入和企业管理要求及水准的提升，5S以增加了平安〔SECURITY〕称为6S。

1S——整理定义：区分“要〞与“不要〞的东西，对“不要〞的东西进行处理。

目的：腾出空间，空间活用，防止误用，塑造清爽的工作场所。

2S——整顿〔定义：对整理这后留在现场的必要物品分门别类放置，排列整齐，明确数量，并进行有效地标识。

目的：工作场所一目了然，消除寻找物品的时间，整整齐齐的工作环境，消除过多的积压物品。

3S——清扫定义：清扫就是点检，清扫是规格化的去除工作。

目的：去掉问题发生根本点，减少工业伤害，维护平安生产，培养发现问题的习惯是零故障的根底，消除不利于产品质量与环境的因素，减少对人们健康的伤害。

4S〕——清洁定义：将上面3S的实施制度化并维持成果。

目的：消除脏污保持职场骨干净明亮，稳定品质，减少工业伤害。

5S——素养定义：提高全员文明礼貌水准，培养每位员工良好的习惯，并遵守规那么做事。

目的：培养具有良好的习惯，遵守规那么的员工，提高员工文明礼貌水准，营造团员精神。

6S——平安定义：人身不受伤害，环境没有危险。

目的：创造对人、企业、财产没有威胁的环境，防止平安事故的苗头，减少平安隐患。

GMP英语PIC/S的全称为:Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S（制药检查草案）, 药品检查协会（PIC/S) ，也有人称PIC/S为医药审查会议/合作计划（PIC/S）PIC的权威翻译：药品生产检查相互承认公约API（Active Pharmaceutical Ingrediet）原料药又称：活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统;Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area洁净区;Consignmecnt(Delivery）托销药品。

FDA(FOOD AND DRUG ADMINISTRATION）：(美国）食品药品管理局IND(INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段，相对于NDA而言);研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束)NDA（NEW DRUG APPLICA TION)：新药申请ANDA(ABBREVIATED NEW DRUG APPLICATION）：简化新药申请TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF(DRUG MASTER FILE):药物主文件（持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER:DMF持有者CFR（CODE OF FEDERAL REGULATION）：（美国)联邦法规PANEL:专家小组BA TCH PRODUCTION：批量生产；分批生产BA TCH PRODUCTION RECORDS:生产批号记录POST—OR PRE—MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG(OVER—THE—COUNTER DRUG）：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOV A Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA）CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch （DR，Product Evaluation & Registration Division, CPAEDQM （European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority （HSA)HSA's Medicines Advisory Committee （MAC）IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data—Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non—proprietary Name International Conference on Harmonisation （ICH）IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare （Japan）MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs）new drug applications （NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics（SPC）Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．A．A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity （Image）企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GA TT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HV AC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典。