【正文】 ards/contamination associated with a product, production process or practice. HACCP是一種較有體系的方法，使產(chǎn)品在生產(chǎn)實(shí)踐過程中，對產(chǎn)品生物化學(xué)物理技能等方面的風(fēng)險(xiǎn)及嚴(yán)肅性的審查及評估。 Scope Applicable to manufacturers and importers of finished devices. Does not apply to manufacturers of ponents, but they are encouraged to use appropriate provisions as guidance. Establishes authority Addresses foreign manufactures exporting devices to the . Addresses exemptions or variances to the cGMPs. Subsection of definitions (167。 Personnel General Sufficient personnel with necessary education, training, background and experience Training Training procedures Personnel are adequately trained Documented 71 Medical Device cGMPs Subpart D – Document Controls 167。 Purchasing Controls (continued) Purchasing Data Purchasing data shall clearly reference specified requirements for purchased products. Include, where possible, agreement of suppliers to notify manufacturer (KC) of changes in purchased product. Purchasing data shall be approved in accordance t。 effective date 72 Medical Device cGMPs Subpart E – Purchasing Controls 167。 Management Responsibility Quality Policy Management with Executive responsibility establishes policy, objectives and mitment to quality. Management with Executive responsibility ensures quality policy is understood, implemented, and maintained throughout the anization. Organization Establish and maintain adequate anizational structure Responsibility amp。 ? 地板，墻壁和天花板必須平整的建筑，并較易的可做表面清潔和良好的維修。 Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 級別三的產(chǎn)品通常是那些用以支持和維護(hù)人類生活，并避免發(fā)生人體傷害或潛在及不合理的傷害風(fēng)險(xiǎn)的具有實(shí)質(zhì)重要性的產(chǎn)品。 7 Food and Drug Administration 食品和藥物管制 Basic FDA Product Requirements ? Safe for intended use ? Drugs and devices effective for intended use ? Not adulterated (., contains what, and only what, it is supposed to contain) ? Not misbranded (., labeled as it should be) ? Manufactured in pliance with applicable cGMPs ? 美國聯(lián)邦政府食品藥物管制基本要求 ? 產(chǎn)品用途安全性 ? 藥品及設(shè)備有效使用 ? 未滲入次品（如產(chǎn)品包含成分，僅有成分等） ? 無錯(cuò)誤標(biāo)記（如標(biāo)簽） ? 按照可行的最新食品及藥品生產(chǎn)質(zhì)量規(guī)范進(jìn)行生產(chǎn) 8 Why do we need GMP’s 我們?yōu)楹涡枰幤飞a(chǎn)管理規(guī)范？ a. Where is KC going? b. Liability c. Compliance (FDA audits and reports) d. KC在哪些方面實(shí)施？ e. 職責(zé) f. 承諾 (美國聯(lián)邦政府食品藥物管理局審核和報(bào)告） 9 KC Direction KC引言 ? “ A host of internal and external challenges are driving significant change within KimberlyClark. Therefore, we are making changes to bee a winning global health and hygiene pany.” (taken from the KC Intra GBP site) ? 一系列內(nèi)外部的挑戰(zhàn)正隨著金伯利發(fā)生著強(qiáng)大的變化。 6 Food and Drug Administration 食品，藥品規(guī)程 The . Food and Drug Administration (FDA) is a public health agency that is charged with protecting American consumers by enforcing the . Federal Food, Drug, and Cosmetic Act and other related public health laws. 美國食品藥物管理局是通過實(shí)施美國聯(lián)邦政府食品藥物管制及其他相關(guān)公眾健康法規(guī)，以確保美國消費(fèi)者健康的公眾機(jī)構(gòu)。 Examples of Class II devices:二級別產(chǎn)品舉例： Surgical drapes 外科醫(yī)用臺布 Tampons 止血棉塞 18 Medical Device cGMPs 醫(yī)療產(chǎn)品的 cGMPs Class III 等級 III Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. 級別三是最嚴(yán)格的級別，三級別的產(chǎn)品是指除了一般和特殊控制外，還未有足夠的信息以確認(rèn)產(chǎn)品的安全性的產(chǎn)品。 41 Why use HACCP? 為何適用危害分析關(guān)鍵控制點(diǎn) It’s all about making Safe and Clean products and meeting Good Manufacturing Practices!!! 一切都是為了生產(chǎn)安全整潔的產(chǎn)品 ? Regulatory requirements 調(diào)整要求 ? Competitive advantage for identification of design issues early 設(shè)計(jì)版本及早的確認(rèn)具有競爭性的優(yōu)勢 ? Protection for product liability awards 產(chǎn)品審查責(zé)任的保護(hù) ? Learn about HACCP as a tool for assessing contamination risks 學(xué)習(xí) HACCP作為評價(jià)混淆風(fēng)險(xiǎn)的工具 43 GMP Next Steps GMP下階段 ? Impact on North Asia ? Korea ? China ? Taiwan ? 對北亞的影響 ? 韓國 ? 中國 ? 臺灣 ? Plans for implementation 計(jì)劃實(shí)施 ? Training 培訓(xùn) ? Project Management 項(xiàng)目管理 44 The 3 Keys to Success with GMP’s GMP’s成功的三點(diǎn)關(guān)鍵 1. Critical Start – Infrastructure and Systems 2. Avoid Surprises – Communicate and plan Early 3. Product – Design, Development, Process and Approvals 4. 開始評論 構(gòu)造和體系 5. 避免意外事件 及早溝通與計(jì)劃 6. 產(chǎn)品 設(shè)計(jì)，發(fā)展進(jìn)程和認(rèn)可 45 Resources 資源 ? GRSA ? Regulatory Affairs ? CART (Compliance and Resource Team) ? Global Capability Teams ? Business Quality Leaders ? 規(guī)程 ? CART（資源團(tuán)隊(duì)） ? 全球力量團(tuán)隊(duì) ? 商業(yè)質(zhì)量領(lǐng)導(dǎo) 46 Questions 問題 47 Appendix A 附錄 A ? Cosmetic and Drug GMP?s ? 美容及藥品生產(chǎn)質(zhì)量操作規(guī)范 48 Cosmetic / Drug GMP’s 美容及醫(yī)藥生產(chǎn)質(zhì)量操作管理規(guī)范 ? Buildings and Facilities 生產(chǎn)場地及設(shè)備 ? Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance. ? Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair. ? Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk. ? 生產(chǎn)場地是指用于合適尺寸，設(shè)計(jì)的美容產(chǎn)品的生產(chǎn)和儲存，并用于設(shè)備的堆放，日常原料的儲存，衛(wèi)生的操作以及適度的清潔和維護(hù)。 ) 67 Medical Device cGMPs Subpart B – Quality System Requirements 167。 Document Controls Procedure shall be established and maintained to control all documents required by the cGMPs Document approval and distribution Designated individual(s) Available at use Controlled Document changes Reviewed and approved Communicated Change records – description, identification of affected documents, signatures, approval date,