精品资料--大学扩招断了平民子弟晋升之路(精校完美打印版)

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高校扩招启示录

他们来做我们的设计人员，设计人员必须要有丰富的实践经验才能出彩，刚从学校出来只懂书本知识不了解我们的消费者需要什么，叫他们如何设计得出畅销的服装呢？你
一
适龄青年受高等教育的比例从１９９１年的３％上升到
１％，３从世界排名第１１，３位上升到了第１位。１４
兴行动计划》，计划寅稀到２１００年实现大学Ｅ入学率达到
的那天．全家人之兴奋．爷当场向我表示婴拿出他的爷
ｉ％，５后来制定“ 十五 ” 计划时．这个目标被提前了５．年即
６交友如果没有离别人就不能真正珍惜相聚的时刻；如果没有离别。人间就再也没有重逢的喜悦。
转变就业观念擦皮鞋
后却遇到了不少
的问题。家长们在高兴之余也不会
想到他们的子女
在本刊记者的采访过程中，在公共汽车上碰到一名戴眼镜的师傅说：记得《人才市场报》曾经举行过一次 “ 如何看待大学生擦皮鞋、两种就业观念大碰撞 ” 的讨论，出的结得论是：大学生甘做擦鞋匠，这是就业观念的积极转变，果如这样的话，就业之路就要大大宽广起来了！然而。如果大量大学生都有这样的观念，麻烦也不会小：国家花近２Ｏ年时间栽培一个人才，这太不值得了！更为重要的是，因为许多大学生“ 力都不是很好” 所以很有可能他们擦的皮鞋比视。
近几年来，校一再扩招。高高校门槛一降再降（特别说明：今年高校已经开始限招）结果是圆了一大批高中生的，大学梦。而带动了高校、从普高的繁荣发展。圆了大学梦的同学自然是高兴

GFI _216 - Final Guidance -CMC- Fermentation-2[1]

#216 Guidance for Industry Chemistry, Manufacturing, and Controls (CMC) Information — Fermentation-Derived Intermediates, Drug Substances, and RelatedDrug Products for Veterinary Medicinal Use Comments and suggestions regarding this guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can be submitted electronically on the Internet at. All written comments should be identified with the Docket No.FDA-2011-D-0112.For questions regarding this document, contact Michael J. Popek, Center for Veterinary Medicine, (HFV-144), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (240) 276-8269, e-mail: michael.popek@.Additional copies of this guidance document can be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/d efault.htm.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary MedicineMarch 8, 2012TABLE OF CONTENTSI.INTRODUCTION (4)II.BACKGROUND (4)III.SCOPE (5)IV.INTERMEDIATES, DRUG SUBSTANCES, DRUG PRODUCTS (5)A.Identification of Manufacturing Facilities (6)B.Description of Manufacturing Process and Controls (6)1.Pharmaceutical Development Reports (6)2.Cell Growth (Propagation) and Harvest (6)3.Purification and Downstream Processing (7)4.Modification Reactions (If Applicable) (8)a.Chemical Modifications (8)b.Enzymatic Modifications (8)5. Reprocessing, Reworking, Recycling, Regeneration, and Salvaging (8)C.Control of Materials (8)1. Microorganism (8)2.Cell Bank System (9)a.Master Cell Bank (9)b.Working Cell Bank (9)3.Media Components (9)4.Solvents, Reagents, Auxiliary Materials (9)D.Control of Critical Steps and Intermediates (10)E.Non-Critical In-Process Controls (10)F.Process Validation and/or Evaluation (10)G.Characterization (10)1.Elucidation of Structure and other Characteristics (10)a.Structural Elucidation (11)b.Physicochemical Characterization (11)c.Biological Activity (11)2.Impurities (11)3.Degradation Products (13)H.Control of Intermediates, Drug Substances, and Drug Products (13)1.Specifications (13)2.Analytical Procedures (13)3.Validation of Analytical Procedures (14)4.Reference Standards or Materials (14)5.Batch Analyses (14)I.Container Closure System (14)beling (14)K.Stability Summary and Conclusions (15)1.Batch Selection for Stability Studies (15)2.Expiration Date versus Retest Date (15)3.Postapproval Stability Protocol and Commitment (16)4.Stability Data (16)Guidance for IndustryChemistry, Manufacturing, and Controls (CMC) Information — Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal UseThis will represent the Center’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.I. INTRODUCTIONThis guidance provides recommendations on what documentation to submit to support the chemistry, manufacturing, and controls (CMC) information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use. This information is filed to the Center for Veterinary Medicine (CVM) in a new animal drug application (NADA), conditional new animal drug application (CNADA), investigational new animal drug file (INAD), abbreviated new animal drug application (ANADA), generic investigational new animal drug file (JINAD), drug master file (DMF), or veterinary master file (VMF).FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.II. BACKGROUNDFermentation processes are frequently used to manufacture intermediates, drug substances, and related drug products for veterinary medicinal use. Traditionally, most manufactured fermentation products were extracted from the media or cell mass and either further purified or molecularly modified to create another entity. Today, a variety of products are manufactured from fermentation processes, including:∙Biomass products (i.e., drug and cell mass constitute the product)∙Competitive exclusion products (i.e., the product consists of one or more microorganisms intended to exclude harmful bacteria, such as Salmonella, from colonizing)∙Biotech productsBacteriophage productsMicrobial systems can introduce manufacturing variability that can affect the purity and quality, and ultimately, the safety and effectiveness of a product, if not controlled. Even though fermentation is a common manufacturing practice, CVM currently provides no CMC guidance to pharmaceutical sponsors about fermentation-derived intermediates, drug substances, or related drug products.III. SCOPEFiling information for the CMC of a new animal drug application is described in 21 CFR 514. The first specific mention of CMC requirements for fermentation products occurs in 21 CFR 514.1(b)(4)(iii)(a-e) in the Component and Composition section. Most other required CMC information is described in 21 CFR 514.1(b)(5). This guidance provides recommendations for CMC information to support fermentation-derived intermediates, drug substances, and related drug products intended for veterinary use.The information in this guidance loosely follows the International Conference on Harmonisation (ICH) Common Technical Document (CTD). Due to the redundancy of information between fermentation-derived intermediates, drug substances, and drug products, sections were combined and are not specifically labeled in the CTD format (e.g. Description of Manufacturing Process and Process Controls (S.2.2)). In addition, some CTD sections may have been omitted as they are common to all intermediates, drug substances, and drug products (e.g. General Information), whether or not they relate to fermentation. CVM will accept quality related documents in CTD format.This guidance does not address postapproval changes associated with fermentation-derived products. Although the guidance addresses fermentation issues associated with semi-synthetic drug substances, it only provides limited information for some semi-synthetic steps post-fermentation. More detailed post-fermentation recommendations can be found in the CVM guidance for industry 169: Drug Substance Chemistry, Manufacturing, and Controls Information. Additionally, this guidance does not address special characterization and control requirements for biomass, competitive exclusion, phage, and other fermentation-related products produced by microorganisms genetically engineered using recombinant DNA (rDNA) technology. Even though these products are not specifically covered, the underlying fermentation principles described in this document would be applicable to these products as well.SUBSTANCES, DRUG PRODUCTSIV. INTERMEDIATES,DRUGCMC information for fermentation-derived intermediates, drug substances, and related drug products can be provided directly in a NADA, CNADA, INAD, ANADA, or JINAD. Typically, the information for intermediates and drug substances are provided by reference to a DMF or a VMF.Master files provide an avenue for manufacturers to submit proprietary information to the Agency without submitting that information to the applicant. Master files can also be used by a drug sponsor as an organizational tool for different processes (e.g., to separate the process for drug substance manufacturing from the finished dosage form process). For the Agency to review aDMF or VMF, a letter of authorization (LOA) from the DMF or VMF holder should be submitted as part of the referencing submission provided by the applicant.The following describes information that should be provided in either a master file(s) or an application, depending on which is used.A. Identification of Manufacturing FacilitiesFacilities involved in the manufacture and/or testing (including contract manufacturers and testing laboratories) of fermentation-derived intermediates, drug substances, and related drug products should be identified. The name, address, and manufacturing responsibility operations/processes performed should be provided for each firm.B. Description of Manufacturing Process and ControlsA detailed description of the manufacturing process and process controls should be provided for intermediates, drug substances, and related drug products:∙Describe the entire process (including original inoculum, propagation, harvest, isolation/purification, and any modification reactions)∙Identify all process controlsFor drug products, a master batch record covering the entire process including original inoculum, propagation, harvest, isolation/purification, and any modification reactions should be provided. Recommendations for executed (completed) batch records are provided in CVM guidance for industry 42: Animal Drug Manufacturing Guidelines-Series of Four Guidelines (1994). CVM encourages the submission of executed batch records for lots of drug substance and drug product used in support of the application as they provide valuable detail and insight into the manufacturing process and proposed controls.1. Pharmaceutical Development ReportsSponsors are encouraged to provide pharmaceutical development reports (PDRs) that describe the scientific rationale for the chosen manufacturing process(es) and controls for fermentation-derived intermediates, drug substances, and related drug products. A sponsor’s ability to demonstrate process understanding can be factored into CVM’s risk-based decision making (e.g., Pre-Approval Inspection Decision Support System (PAIDSS)). Suggestions for PDRs can be found in ICH Q8: Pharmaceutical Development.2. Cell Growth (Propagation) and HarvestA description should be provided that includes a flow diagram illustrating each step in propagation from the original inoculum (e.g., cells from one or more vials of the working cell bank) through the last harvesting operation.∙All steps should be included along with the relevant information, such as the growth conditions and in-process tests performed (e.g., cell concentrations, volumes, pH,cultivation times, temperatures).∙Critical steps and intermediates for which specifications are established should be identified, along with sampling plans and testing time points.∙The flow diagram can be supplemented with information presented in tabular form, if appropriate.A narrative describing each manufacturing step in the process should accompany the flow diagram:∙Identify all process controls and the associated numeric ranges, limits, or acceptance criteria∙Highlight any process controls that are considered critical∙Identify the intended scale of the process. The amounts indicated should be representative of a maximum-sized production batch.We recommend the following be included in the narrative:∙ A description of the major equipment involved in each step∙ A description of inoculation and each step in propagation with growth conditions specified∙The composition of the media used at each step, including water quality and additives used∙The sterilization procedures for media (e.g. a batch sterilization process or continuous system)∙The equipment (e.g. fermentation vessel), feeds, and other materials added during the fermentation process∙Process parameters monitored and controls for critical steps and intermediates∙Procedures used to transfer material between steps∙Procedures used to minimize contamination by adventitious agents∙Process controls to confirm the effectiveness of the specific manufacturing steps used to inactivate and or remove adventitious agents∙Criteria for harvesting∙Criteria for rejecting/accepting a fermentation batch if contamination occurs∙The determination of yields∙Criteria for pooling more than one harvest, if applicable∙Storage conditions and time limits if the harvested crude fermentation product is held prior to further processing3. Purification and Downstream ProcessingThe description should include a flow diagram that illustrates and a narrative that describes all the steps involved in isolating and purifying the crude fermentation product to its final form, along with any relevant information (e.g., volumes, pH, temperatures, holding times). Critical steps and intermediates for which specifications are established should be identified, along with testing time points.The narrative describing each manufacturing step should accompany the flow diagram and should identify all process controls and the associated numeric ranges, limits, or acceptance criteria and include the following:∙Methods used in purification or separation of the crude fermentation product (e.g.precipitation, centrifugation, filtration) including major equipment (e.g. columns, membranes∙Process parameters monitored∙The in-process controls and analytical tests used to show identity, purity, and concentration and to evaluate levels of process- and product-related impurities ∙The determination of yields∙Precautions taken to prevent or control microbial contamination during purification∙Conditions for reuse and/or procedures for regeneration of columns, membranes, and adsorbents∙Storage conditions and time limits, if the purified fermentation product is held prior to further processingReactions (If Applicable)4. Modificationa. ChemicalModificat ionsWhen a product of fermentation is to be subjected to further molecular change through chemical means, a description of the synthetic steps should be included in the procedural narrative. Additionally, a flow diagram of the synthetic process should be provided. For more details, see CVM guidance for industry 169: Drug Substance: Chemistry, Manufacturing, and Controls Information.Modificationsb. EnzymaticWhen the fermentation product is further modified using enzyme catalysts, the steps should be included in the flow diagram and detailed in the procedural narrative. Enzymatic reactions are considered chemical reactions since the conversion of substrate product involves breaking and forming chemical bonds. Thus, much of the information submitted in the manufacturing description should be the same as that submitted for chemical processes (drug substance). However, because enzymatic functionality requires carefully controlled conditions (e.g., pH, temperature, osmolarity), the description should contain detailed information on reaction controls and the optimum range of operation. Furthermore, the biological source of the enzyme should be provided along with a description of the enzyme’s preparation and information about its purity.5. Reprocessing, Reworking, Recycling, Regeneration, and SalvagingWhen appropriate, reprocessing, reworking, recycling, regeneration, and salvaging operations should be described. For more detail, see CVM guidance for industry 169: Drug Substance: Chemistry, Manufacturing, and Controls Information.MaterialsC. ControlofA list of materials used in the manufacture of fermentation-derived intermediates, drug substances, and drug products should be provided (i.e., the microorganism, cell bank system, media components, solvents, reagents, auxiliary materials). Information pertaining to the quality and control of these materials should also be provided.Microorganism1.Information about the microorganism used for production (i.e., genus, species, and type strain) and known genotypic and phenotypic characteristics should be provided. Additionally, the origin of the source material (or isolate) should be identified or described.2. Cell Bank SystemBanka. MasterCellA brief description of the procedures used to generate the master cell bank (MCB) and the criteria used for qualification should be provided. The information should include:∙Method, reagents, and media used in preparation∙Date of preparation∙Process controls∙Storage conditions∙Procedures used in testing for relevant phenotypic and genotypic markers and determining culture purity∙Procedures used to ensure the absence of contamination from adventitious agents (e.g., microbial contamination and cross–contamination by other cell types) with tests andacceptance criteria specifiedb. Working Cell BankPreservation of the microbial purity of the MCB is an important factor in maintaining the production strain. Often a working cell bank (WCB) is created so that the MCB will be less likely to be compromised. Creation of a WCB occurs via the propagation of the MCB through defined culture conditions, and then aliquots of the resultant homogenous culture suspension are partitioned into individual storage containers of appropriate size for routine production purposes.A brief description of the procedures used to derive a WCB from the MCB and the criteria used for qualification should be provided. Information similar to that submitted for the MCB should also be submitted for the WCB.Components3. MediaA list of the media components used at each stage of the fermentation process should be included in the submission. Specifications should be provided for each component for verification that the material is of suitable quality for its intended purpose.∙If ruminant-based media components are used in the fermentation process, they should comply with the proposed BSE Medical Products Rule, issued on January 12, 2007 (72FR 1582).∙All animal-derived components should be identified and appropriate mitigation steps taken to prevent the transmission of adventitious agents.4. Solvents, Reagents, Auxiliary MaterialsA list of solvents, reagents, and other auxiliary materials used in the fermentation process should be provided. Specifications for each material should be included for verification that the materialis of suitable quality for its intended purpose. When water is used in the process, it should be of an appropriate quality for its intended use.D. Control of Critical Steps and IntermediatesAll critical process controls and their associated numeric ranges, limits, or acceptance criteria should be identified and justified and a brief description of the test provided. Furthermore, any experimental data to support the justification should be included.∙Good controls are essential during fermentation to ensure product consistency.∙End product testing alone is not adequate for demonstrating a fermentation process is under control.∙Manufacturing processes, including fermentation, should be controlled to ensure that the product meets previously identified quality attributes.All controls used in determining an isolated intermediate’s acceptability for downstream processing should be identified. When the intermediate represents the end of the fermentation process and the beginning of a synthetic scheme, the controls warranted are generally more extensive than those used for other types of intermediates. For more detail, see CVM guidance for industry 169: Drug Substance: Chemistry, Manufacturing, and Controls Information.E. Non-Critical In-Process ControlsCVM encourages sponsors to identify and describe non-critical in-process controls conducted on a routine basis (e.g., carbohydrate burn rate, may affect yield, but won’t necessarily affect product quality). Although these controls may not directly demonstrate that a process produces a quality product, a description of the tests being conducted and why they are not critical, aid in demonstrating process understanding.F. Process Validation and/or EvaluationWhen a fermentation-derived intermediate, drug substance, or drug product is sterilized, the process validation information and data in support of the sterilization process(es) should be provided. Refer to CVM guidance for industry 48: For the Submission of Documentation for Sterilization Process Validation In Applications For Human And Veterinary Drug Products. Non-sterile process validation is conducted prior to commercial marketing. CVM may request that process validation protocols and data be submitted in support of manufacturing processes. Scale-up issues encountered during process validation and any modifications to the process to accommodate these issues must be reported through the appropriate postapproval submission process (see 21 CFR 514.8(b)).G. CharacterizationStructure and other Characteristicsof1. ElucidationConfirmation of the structure and characterization data for a fermentation-derived intermediate, drug substance, or drug product should be provided. When the fermentation product is a mixture of active components, isolation and purification of individual components for structural analysis and characterization may be appropriate.a. StructuralElucidationStructural confirmation using physical and chemical techniques (e.g., elemental analysis, mass spectrometry, infrared spectroscopy) should be provided for the intermediate or drug substance. Additionally, the data and details of its interpretation should be included. The amount of data warranted to support the elucidation of structure can vary depending on the complexity of the molecule. For USP labeled drug substances, structural confirmation can be accomplished by demonstrating conformance to a USP reference standard.Characterizationb. PhysicochemicalThe kind and extent of the physicochemical characterization information that should be provided depends on (1) the type of drug substance (e.g., semi-synthetic molecule, protein), (2) the type of dosage form in which the drug substance will be used, (3) the ability or tendency of the drug substance to occur in one or more solid state forms, and (4) the importance of the differences in physical characteristics of the different forms to the stability, dissolution, or bioavailability of the drug product. For more details on the type of information that should be submitted, see CVM guidance for industry 169: Drug Substance: Chemistry, Manufacturing, and Controls Information, Draft Guidance.Activityc. BiologicalWhen a biological assay (e.g., antimicrobial activity for antibiotics) is used to assesspotency/strength of the intermediate or drug substance, biological activity data should be provided to complete the characterization profile. Data should be provided on the reference standard lot or other relevant lots to demonstrate the potency/strength of the intermediate, drug substance, or drug product.In some cases, the product of fermentation is a complex mixture of major and minor components that together make up a product’s biological activity. In evaluating the impurity profile for these fermentation products, efforts should be made to identify and characterize the active components (major and minor) that contribute to the product’s overall potency and distinguish them from impurities. This may not be practical or feasible in all cases. We recommend an applicant with related questions consult the appropriate review team for additional guidance.2. ImpuritiesInformation concerning impurities in the fermentation-derived intermediate, drug substance, or drug product should be provided (e.g., organic impurities, inorganic impurities, and residual solvents).∙Impurities may derive from the manufacturing process (e.g., residual media components, residual protein and nucleic acid derived from microbial cells, processing reagents,inorganic salts, filter aids, solvents), or they may be structurally related to the desiredfermentation product, but not share the same properties with respect to biological activity, efficacy, and safety (e.g., other microbial metabolites, precursors, by-products).∙Process related impurities derived from the fermentation and downstream processing should be minimized as much as possible through the use of a well-controlled andreproducible manufacturing process.Structurally related impurities should be identified, tracked, and controlled throughout the fermentation, isolation, and purification processes.A summary should be provided of the impurities most likely to arise during the fermentation, isolation, purification, and storage (e.g., holding time) of the intermediate, drug substance, or drug product. The summary should include impurity profiles (i.e., chromatograms), test results from representative batches, and results from forced degradation studies used to identify the potential impurities that may arise during storage. The impurities reported can be of known structure, partially characterized, or unidentified. Studies done in characterizing the structure of impurities should be summarized. Documentation should also be provided demonstrating that the analytical procedures used in quantifying impurities are properly validated or qualified.The specifications for fermentation-derived intermediate, drug substance, or drug products should include limits for impurities (i.e., organic impurities, inorganic impurities, and residual solvents). Additionally, a rationale for the inclusion or exclusion of impurities in the specifications should be presented. As appropriate, this rationale should include a discussion of the impurity profiles observed in batches used for clinical, safety, and stability testing, as well as batches representative of the proposed commercial process.Although relevant guidances (92: Impurities in New Veterinary Drug Substances, VICH GL10 (R) and 93: Impurities in New Veterinary Medical Products, VICH GL11(R)) on impurities did not address fermentation products, the principles described in these guidances are still applicable. Furthermore, levels for reporting, identifying, and qualifying organic impurities as described in these guidances are applicable to non-complex, well-characterized fermentation products.For complex fermentation products that are not well-characterized in terms of structure, physicochemical properties, biological activity, and purity, it is recommended that the levels for organic impurities be determined on a case-by-case basis.The acceptable levels for organic impurities will also depend on how the fermentation product is to be used. The levels will likely be less stringent for a drug substance or an intermediate that will be subjected to further modification and/or purification compared to that of a drug product that does not undergo further processing.For inorganic impurities and residual solvents, limits should generally be based on pharmacopeial standards (e.g., USP General Chapter <467> Residual Solvents) or known safety data. Additionally, the ICH guidance Q3C Impurities: Residual Solvents or the CVM guidance 100: Impurities: Residual Solvents in New Veterinary Medical Products, Active Substances, and Excipients, VICH GL18(R) should be consulted, as appropriate.For most fermentation products (e.g., antibiotics), it is expected that purification and downstream processing effectively remove process-related impurities, such as residual media components, residual protein and nucleic acid-derived from microbial cells, and other processing reagents. Thus, in most cases, limits need not be included in the specification for these impurities. However, when studies suggest that process-related impurities are not effectively removed from the purification process, these impurities should be controlled with limits in the specifications, as appropriate.Microbial impurities tests (e.g., for endotoxins) for drug products may be required based on the intended route of administration of the drug product in accordance with 21 CFR 514.1(5)(xi). In some instances when there is a safety concern, drug substances (e.g., gentamicin sulfate) may。

序

序—高校扩招
（一）高校扩招的背景：
3. 有人想到了教育。中国人对教育的重视甚至崇拜可谓世界闻名。所谓“万般皆下品，唯有读书高”，“再穷不能穷学校，再苦不能苦孩子”。基础教育已经没有潜力可挖，只能打高等教育、也就是大学的主意。
序—高校扩招
（一）高校扩招的背景：
3.能上大学，一直是孩子和家长的共同期待，是让孩子和家长特别觉得有面子的事。孩子要能考上大学，就是砸锅卖铁，家长也干。
序—高校扩招
（）高校扩招的影响
“到了2004年，各省高校几乎找不到不贷款的学校了，找到了才奇怪了。” 邬大光说。
序—高校扩招
（二）高校扩招的影响
消极影响之二：高校教育质量滑坡由于经费不足，高校教学资源出现全面紧张，特别是教师队伍、教学设施、食堂、学生宿舍等。大学生就业难逐渐成为一个广为关注的社会问题。
（一）高校扩招的背景：
1.于是人们将目光开始转向国内市场，而恰在此时我国经济出现通货紧缩的趋势，投资减少，消费疲软，国内消费市场增长并不迅速，导致经济增长缺乏原动力。如何扩大内需，成为高层决策的面临的重大课题。
序—高校扩招
（一）高校扩招的背景：
2. 1999年，我国城乡居民储蓄存款余额为59621亿元。表面看来，中国老百姓不是没钱，而是舍不得花钱。怎样让这些人心甘情愿地把钱掏出来花，从而刺激消费、扩大内需，从而促进国家经济增长呢？
（四）教育活动体现了自觉性和强制性的统一 P46
（五）教育效果具有现实性和未来性
的统一
P47
迟效性与长效性
三、教育的产生
（一）生物起源论（二）心理起源论（三）劳动起源论（四）生活需要起源论
P48-49 P49 P49-50

晋位升级方案(2篇)

晋位升级方案在当今社会，随着经济的快速发展和科技的不断进步，大家都希望自己能够得到更好的发展机遇和提高自身的职业水平。

尤其是在工作中，晋升成为一个永远的话题，因为晋升代表着职业的提升和收入的增加，能够提升自己在组织中的地位和权力，因此，如何更好地制定晋升计划成为了很多人关心的焦点。

晋升并非是一蹴而就，而是需要我们从自身的各方面进行改善和提升，从而获得更好的发展机会。

首先，我们需要提升自身的专业能力。

随着社会的快速发展，专业知识更新迅速，如果我们停留在原地不前进，就会被淘汰落后。

因此，不断学习新知识，提升专业技能是我们提升的必由之路。

其次，我们还需要提升自身的综合素质。

作为一个优秀的员工，不仅需要具备扎实的专业知识，还需要具备良好的沟通能力、团队合作能力、领导能力等综合素质。

只有具备这些素质，才能在工作中更好地发挥自己的作用，得到老板和同事的认可，从而获得晋升的机会。

提升综合素质还需要加强自身的自我管理能力。

在工作中，我们常常会遇到各种各样的问题和挑战，如果没有良好的自我管理能力，就容易被琐事耽误了自己的发展方向。

因此，我们需要学会合理安排时间，做好工作和生活的平衡，通过有效的时间管理和情绪管理，更好地提升自己的综合素质。

在晋升的过程中还需要加强自身的职业规划能力。

职业规划是指个人根据自己的兴趣、能力和目标，对未来职业发展进行系统的规划和安排。

只有有明确的职业规划，才能更好地确定自己的发展方向，从而获得更多的发展机会和晋升机会。

因此，我们需要制定长远的职业规划，不断评估和调整自己的发展方向，以便更好地实现晋升的目标。

对于晋升来说，领导对个人能力的认知非常重要。

因此，我们需要积极主动地展示自己的能力和价值，让领导认识到自己的工作表现和潜力。

通过担任重要任务或项目的负责人，积极主动提出优化方案，展现自己的领导潜力，让领导信服自己有能力胜任更高职位的挑战。

另外，在工作中要主动承担挑战，勇于接受新的工作和任务，展现出自己的积极进取精神和责任意识。

高校扩招_一把_双刃剑_我国高校扩招10年回顾与认识_陈伟民

第10卷第3期广东工业大学学报(社会科学版) V o.l 10N o.32010年6月Journa l of G uangdong University of Techno l ogy(Social Sci ences Ed ition) J un .2010收稿日期:2009 12 24作者简介:陈伟民(1968 ),男,汉族,讲师,本科;主要研究方向:高等教育研究。

高校扩招:一把双刃剑我国高校扩招10年回顾与认识陈伟民(广东工业大学招生办公室,广东广州,510006)摘要:从1999年到2009年,我国高校的扩招走过了整整十个年头,教育也已经从之前的精英教育转向了大众化的教育。

高校扩招政策的方向是正确的和合理的,但同时也存在一些不利因素。

文章在分析高校扩招的背景积极因素和不利因素的基础上提出了相应的对策建议。

关键词:高等院校扩大招生高等教育大众化十年回顾中图分类号:G 640 文献标识码:A 文章编号:1671 623X (2010)03 0013 04一、高校扩招回顾在20世纪90年代之前,中国大学生的学费、住宿费等是由国家负担。

但随着经济的发展、适龄青年的增多,由国家对高等教育进行全包的教育模式,影响了我国高等教育的发展,高等教育规模跟我国社会和经济发展速度极不相适应。

各个阶层从各自的层面在为中国教育的发展寻找出路。

在此背景之下,1998年11月,亚洲开发银行驻北京代表处首席经济学家汤敏,以个人名义向中央写信,提出关于启动中国经济有效途径扩大招生量一倍的建议书。

他陈述5个理由支持大学扩招:其一,当时中国大学生数量远低于同等发展水平的国家;其二,1998年国企改革,大量下岗工人进入就业市场,如果大量年轻人参与竞争,就业将面临恶性局面;其三,国家提出保持经济增长8%目标,扩招前经济增长率为7 8%,急需扩大内需,教育被认为是老百姓需求最大的;其四,当时高校有能力消化扩招,平均一个教师仅带7个学生;最后也是最重要的,高等教育的普及事关中华民族的整体振兴。

1000051814

D33 D A O B A教育Ma y.2006编辑：宁书林大学扩招，可以说是近年来中国“高招”改革中最高的一招了。

1999年，我国普通高校招生154万人，比1998年增加46万人，增幅高达42.6%。

大学扩招从1999年到2006年，短短7年时间，大学招生几乎呈直线上升趋势，每年递增50万人左右。

由于大学扩招，一些名牌大学为了“创收”，大量招收“线外生”，只好降低入学资格要求；学生数量增加了，学校规模扩大了，管理机制跟不上。

师资力量跟不上，教学基础设施跟不上；校园里教风日下，学风日下，整体素质难以提高。

一些不学无术的小混混，自己不学习，在课堂内外惹是生非，反而闹腾得别人也学不成。

结果高等学校在校学生人数增加了，教育教学成果减少了，培养高素质人才的任务落空了，与国际教育水平的差距扩大了。

大学扩招只是一个花架子，好看不中用。

那么，究竟谁是大学扩招的最大受益者呢？这每年扩招的几十万指标真正用到哪里去了呢？事实很明显，下述三种人才是大学扩招的最大受益者。

第一，教育当局里一些追名逐利之徒。

由于大学扩招投资少，见效快，收益大，有了“政绩”，那些善于投机钻营、惯于见风使舵的人，既能夺得治学专家学者的美名，又能打通一条升官发财的门道，真可谓是一举两得，一箭双雕，何乐而不为呢？第二，各级官家不学无术的花花公子。

由于大学扩招，降低了大学入学“门槛”，各级腐败官宦之家就有了名正言顺的理由，把自己那些染了一身坏毛病，却无半点真才实学的子女，从前门堂而皇之地送进各地高等学府。

于是，“条子生”漫天飞，谁敢说个“不”字？一类大学还不行，要全国重点名牌大学。

在物欲横流的社会中，“一人得道，全家鸡犬升天”的事，是屡见不鲜的。

第三，大小暴发户玩世不恭的混混子。

由于大学扩招，要增加教学“成本”，大学没有钱，上头又给不了那么多，自然要把手伸向社会。

在市场经济的社会里，有人卖什么，就会有人买什么，只要手里有银子就成。

有的人一夜之间成了“百万富翁”，大把的票子“来得容易，去得也容易”，只要能买得到，无论如何也要给自己那混小子捐个“功名”。

十年扩招路漫漫

十年扩招路漫漫投稿信箱 [文稿] greenchina@ [图片]greenchina@都市报调查了从1977年到1999年20多名状元的职业情况后发现，无一人能成为所在行业的领军人物，大多默默无闻，有的甚至成了全职太太。

湖南师范大学教科院副院长丁道群认为，在中国的中学教育和家庭教育中，人们更多关注的是分数，忽视了性格和人际交往能力的培养。

而据中国校友会网高考状元课题研究组专家调查的1400名高考状元，发现大多数内向、高傲、情商低。

如果未在大学调试好，进入社会后短期内将很难适应，对社会的理解、接受度也不高。

当然，现在逃避社会的最好一种方式，就是继续升学。

最新数据显示，2012年，我国研究生(包括硕士生和博士生)的计划招生规模达到了584416人，其中硕士生517200人，博士生67216人。

而在2003年，我国研究生的招生计划规模为267000人。

2012年的招生规模是2003年招生规模的2.18倍，这意味着我国研究生年度招生规模10年来扩招将近一倍多。

根据教育部、国家发改委公布的招生计划数，2012年的博士生招生计划为67216人，而2003年则仅为49201人，首尾年份相比，规模只扩大了36.6%。

2012年硕士生招生517200人，而2003年则只有217799人，首尾年份相比，硕士生规模则扩招了137.5%。

硕士生招生扩招幅度则远超过博士生的扩招幅度。

时事评论人侯金亮发表评论指出，如今很多高校都志在成为“研究型大学”，争建研究生院。

而成为所谓研究型大学的重要标志是研究生的招生数量比肩本科生，甚至超过本科生。

倘若研究生扩招没有与培养质量相联系，而仅仅是数量的增加，则容易导致学历贬值。

另一方面，和当年本科生扩招一样，每年大批的研究生毕业投入就业市场，许多用人单位的录取门槛也越来越高。

不过，就算研究生毕业就更具有职业竞争力了吗？麦可思研究院的最新调研数据显示，2012届本科毕业生计划国内读研的首要理由是“就业前景好”。

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．
业生湮辅导更具人性化，更具个业生涯辅导图分类号：４Ｇ文献标识码：Ａ
文章编号：６３９９（０Ｓ１（）０３一ｌ１７ — ７５２０）２ａ一２３Ｏ
会在真正意义上成长起来。２班级职业生涯辅导强调体验和感悟所谓班级职业生涯辅导，是指以团体２职业生涯规划时个人的自身的问题，职业生涯辅导及相关的理论与技术为指导，以解决学生成长中的职业生涯规划等每个人都有不同的情况，大学生对职业生问题为目标，以班级为单位的集体职业生涯的改变是个体的经验不断改组与改造的过程心理辅导活动是解决个体自身的问涯辅导活动。班级职业生涯辅导不同于一般的班级题，它需要以个体的经验为载体。那么个主题活动与团体心理辅导。具有一定关联人的自我体验就显得尤为重要。我们认为，对学生有意义的自我职业体验应该包与区别性。括职业喜好体验、价值体验和职业素质体班级活动、团队心理辅导与班级职业生涯辅导的对比，从内涵上讲，级职业生验。这些自我体验可以通过在职业生涯辅班营涯辅导同心理团队辅导更相近，所不同的导活动中创设一定的情境，造一定的氛围来实现。可见，班级职业生涯辅导是一是，心理团队辅导仅仅针对少数同质或异质的规模较小的团体，辅导带有发展性或种自我教育活动，它没有说教和灌输等显矫治性的，般需要专业人员来承担；班性教育的痕迹，但可以通过学生自己体验一而级职业生涯辅导课程是以 “ ” 的形式对和感悟，潜移默化地影响他们的对将来职课全班进行职业生涯辅导及人生探索，可以业的认识。在课堂上进行，在课堂以外进行，在时间和２３班级职业生涯辅导以互助．自助为机空间上更为灵活，可以由受过一定培训的制保守的教育观念总是把学生看作教育班主任来承担。的对象，业生涯辅导则提倡学生是教育职的主体。班主任在进行职业生涯辅导的时２班级职业生涯辅导的特点２１班级职业生涯辅导是引导学生进行自候应该积极调动学生自身的教育资源。辅导活动是一种积极的人际互动过程，同龄我探索的职业探索过程个比较完善的学校教育体系应该教伙伴有共同的爱好、价值观和文化背景，给学生三方面的知识：关于自然的知识、彼此之间容易理解和沟通，他们可以不加坦进行心与心的交流，这本关于社会的知识和关于自己的知识。在现掩饰，诚直言，行的学校课程教育中，前两项都得到了落身也是对自身职业素质的提高。班级职业实，独学生对自己了解得很少，惟不知道自生涯辅导活动一般都有主题和目标，它是己真正需要些什么，造成毕业时的工作期依据学生一定的对职业生涯的认识制定容望值普遍出现偏差。班级的职业生涯辅导的，易为学生接受，形成共识。作为集体学生在辅导活动中既是受助者，又就是由班主任有步骤的进行引导，让学生的一员，进行自我探索，认识自我、调节自我。真正是助人者。这种互助可以增进学生对自了解自己的职业价值观、了解自己的职业信、自尊的体验，从而达到自助。

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大学扩招断了平民子弟晋升之路
1999年，中央制定了以“拉动内需、刺激消费、促进经济增长、缓解就业压力”为目标的大学扩招计划，当年招生人数增加51.32万人，招生总数达159.68万人，增长速度达到史无前例的47.4%；之后2000年的扩招幅度为38.16%，2001年为21.61%，2002年为19.46%，此后扩招速度虽明显放缓，但仍维持了每年两位数的增长速度。

目前，我国每年大学毕业的博士、硕士、学士和专科学生数量均稳居世界第一，2010年各种公办、民办的高校毕业生数量达到了700万，与此同时毕业后半年的就业率不到70%，不少大学生毕业即失业的残酷现象已是不争的事实。

支持大学扩招的人认为，大学扩招扩大了国民受教育程度，提高了全民素质，特别是使得更多的农村孩子有了上大学的机会，圆了他们的大学梦，同时由于延长了许多人受教育的年限，减轻了社会的就业压力。

但十多年大学扩招之后，随着中国大学招生规模越来越大，其众多弊端也越来越显露出来，上述支持大学扩招的理由越来越站不住脚，甚至可以说，实际上断了平民子弟为国家奉献聪明才智、改变自身命运的晋升之路。

首先说说大学扩招提高了国民素质这件事。

姑且不论在世界上排不上名次的中国大学批发出来的博士、硕士、学士有多少含金量，实事求是地讲，让更多青年人多读些书、多一些思考的本领，自然对提高全民素质是有利无害的。

但若说大学扩招就提高了全民素质，则实在经不起客观推敲。

首先，人的素质高低与读书多少没有必然相关，个人道德修养并非掌握知识的多寡决定的；其次，人一生的掌握的有用知识，绝大部分来自于生活实践，如今信息时代，一个更早接触社会的初、高中毕业生，所掌握的有用知识，往往并不弱于一个二、三流大学培养出来的找不到专业对口工作的大学生、研究生。

中国培养的博士数量早已是世界第一，可是除了三聚氰胺、瘦肉精、水变油这样的科学发明一度震惊世界，哪一项科技成果足以影响到人类文明和科技进步的进程？！中国今天的高校毕业生是十年前的10多倍，在尔虞我诈、道德沦丧、物欲横流的今天，国民整体素质又高到了哪里？！
其次说说大学扩招圆了农村孩子大学梦这件事。

没错，大学扩招增加了农村孩子读大学的机会，但同时也增加了城市孩子和官二代、官三代、富二代、富三代读大学的机会。

殊不知，一个农村家庭，要担负起一个大学生，父母需要常年的省吃俭用和辛勤劳作，甚至到处举债才能勉强完成学业；孩子快大学毕业时就会发现，没有背景的农村孩子再有本事，也不如专业更差、学业更差、品行更差的城市孩子那样能找到一份体面、养家糊口的工作，更不必跟那样官二代、官三代、富二代、富三代相比。

多年的举债付出、寒窗苦读，最终只落得在城市蚁族窝居甚至漂泊流浪的命运。

有人说，农村孩子在城里找不到工作，为何不回到家乡建功立业呢？这根本就是没有人性的推脱！即使农村孩子大学毕业后狠下心来回乡务农，体力和劳动技能也远不能跟那些没有上过大学的同龄人相比，何况那是对所学知识和付出成本的极大浪费，让这些孩子们情何以堪！
再说说大学扩招缓解了社会就业压力这件事。

延长年轻人的受教育期限，自然是缓解了社会的就业压力，但与此同时，如果接受教育者没有获得一技之长，或者无法找到专业对口的工作，那无疑就是让社会和个人支付了巨大的无用成本，而更可怕的是，一个付出了巨大的时间和经济成本、受过大学教育的人，自然企图找到一份比体力劳动者更加体面、收入更高的工作，一旦社会不能提供这么多相应的职位，其从事低收入和体力劳动的意愿，则远不如没有受过大学教育的同龄人，于是就变得高不成、低不就，面临毕业即失业的悲惨命运。

每年约200万人、近30%大学生毕业即失业的状况，到底是缓解了社会就业的压力，还是加剧了城市就业的严峻形势，从近年来每年不断攀升的大学生自杀数量上可见一斑。

今天促使我写下此文的有两件事。

一件事是亲朋好友聚会中的一次闲聊。

我有一位亲戚的孩子今年将大学毕业，自然聊到
大学毕业找工作的事。

我这才知道，如今临床医学和法律专业的大学生，70%以上找不到专业对口的工作。

我这位亲戚的孩子就是读临床医学，因为恰好另一位亲戚在医院担任领导职务，所以才有机会毕业后顺利安排工作，准备将来继续攻读在职研究生，而听他们讲，即使博士、硕士毕业都很难进上海这家知名医院。

这让我大为感叹。

因为我知道这个孩子资质实在一般，如果不是大学扩招，退回到十年前绝对无法考上大学的，大学期间倒是十分刻苦，但每次考试都是勉强过关，甚至课外活动论文都是我帮助完成的。

联想到现在从上到下都是权力交易，大学扩招实际上打开了特权阶层任人唯亲的方便之门，断送了多少贫民子弟本来可以为国家奉献聪明才智、改变自身命运的机会！除了极少数贫民子弟有机会通过漫长的拼搏改变自己的经济和社会地位，绝大多数人哪怕受过再高的教育、再有真才实学也只能世世代代生活在社会最底层，这是多么残酷的事实！大学扩招与社会腐败的结合，助长了特殊利益集团的权力垄断，加剧了社会不公，从此彻底粉碎了中国几千年来激励读书人奋发进取的“书中自有黄金屋，书中自有颜如玉”、“知识改变命运”的梦想。

这大约是当初倡议大学扩招的经济学家汤敏先生所没有想到的结果。

另一件事是，今天浏览某教育论坛时，无意中看到了一位跳楼自杀博士留下的催人泪下的遗书。

2010年3月
22日，北京邮电大学2009级博士研究生吴某从该校本部主楼坠下身亡，事后警方排除他杀可能，学校认为是生活和就业压力使吴博士走上了绝路。

从吴博士这份遗书中，可以读到他对社会既得利益集团的愤怒控诉，对就业求职前景的极度悲观，对改变知识改变命运的极度失望，对摆脱家庭经济贫困的彻底绝望。

正是这种对社会不公的极度愤怒、悲观、失望和无力改变现状的彻底绝望，促使他从这座曾给予他希望和梦想的高楼上纵身一跳，一了百了，做了彻底的解脱！
中国社会发展到今天，谁都无法改变既成的事实。

今天写下此文，一来感恩邓小平先生恢复高考制度，让我们这些平民子弟依靠知识改变了自己的命运；二来为教育这块被几千人来中国读书人视为神圣的地方，如今完全失陷于权贵腐败之手，替当今绝大多数平民子弟生不逢时的命运，唱一曲无病呻吟的挽歌——庆幸我将自己的儿子送去了美国，期望能提供他一个相对公平的社会竞争环境，将来可以凭自己的聪明才智，谋一份自己力所能及的工作，最重要的是不必看权贵们的脸色说违心的话、办违心的事。

附：《北京邮电大学博士生吴某的绝命书》
想好了。

我想我真的想好了。

这个世界是一沟绝望的死水，我在这里再怎么折腾也激不起半点涟漪。

所有的努力都会被既得利益集团踩在脚下，所有的奋斗都面临着举步维艰。

冷漠的人，谢谢你们曾经看轻我，让我最终下了这样的决心。

世俗的炎凉，尘世的丑恶，恶心的嘴脸，可恶的压力，你们都随风去吧。

对不起。

我可怜的让我万般不舍的妈妈，最对不起的就是你……我此刻一想到你苍苍的白发，粗糙的双手，一年大部分的饭菜只是馒头就咸菜，一件蓝色的夹克穿了那么多年，每年过年都是那一件，我都会心痛得要死。

儿子不孝，不肖，没能让您的付出得到回报，这么多年您一个人含辛茹苦供我一直读到北邮的博士啊……曾经，我所有对您的承诺，都没有办法履行了，对不起，对不起。

妈妈，儿子是一个没有用的人，自从离开老家以来，其实无时无刻不在想着让您也能来北京吃一次烤鸭，看看天安门和故宫，住上楼房，坐上小车，不用再为了我去捡垃圾、拾破烂，不用再去给人家工地上做饭赚钱瞧人家白眼……可是，这么多年了，我什么都没有给您，我甚至连您一直想要却舍不得买的假牙伴侣都没能给您买到，每当晚上躺在床上想到您每顿
饭都在用那戴不牢的假牙痛苦地磨着干涩的馒头，我的眼泪就止不住地流……一百块啊，不过是一百块啊，一百块还不够那些老板官员们抽一盒烟的钱，我却给你买不起！
我太没用了。

现在知识太没用了。

有用的只是金钱和权势，有用的只是关系和背景。

现在要凭正直的才华去出人头地，太难、太难了。

我也曾试着找过工作，但是没有人用我。

我对这个世界彻底地绝望了。

绝望了。

我的肝又开始痛了，不能再写下去了……我走之后，哥哥一家就应该会对您好点了，保重……终于可以一了百了了，我很高兴。

永别了，妈！。