【正文】 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施美國聯(lián)邦政府食品藥物管制及其他相關公眾健康法規(guī)，以確保美國消費者健康的公眾機構。一級別的產(chǎn)品在常規(guī)控制中和級別二三相同。 These changes include, but are not limited to: 這些改變包含以下方面但不僅限于此： ? Design 設計 ? Process 進程 ? Software 軟件 ? Cleaning 清潔 ? Sanitization 清除干凈 37 GMP Controls What needs to be in place? 什么適當?shù)姆矫嫘枰?GMP控制 ? Understand the scope, risk and regulations ? Assess risks – HACCP ? Product History ? 領會范圍，風險及規(guī)章 ? 評估風險 HACCP 危害分析關鍵控制點 ? 產(chǎn)品歷史 38 Risk Assessment Scope 風險評估范圍 39 How do we assess GMP risks? 我們?nèi)绾卧u估 GMP風險？ HACCP is a proactive systematic approach to the identification, assessment of risk and severity, and control of biological, chemical, and physical hazards/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)實踐過程中，對產(chǎn)品生物化學物理技能等方面的風險及嚴肅性的審查及評估。 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。 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 to Document Controls (167。 Quality Audit 69 Medical Device cGMPs Subpart B – Quality System Requirements 167。 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 (continued) ? Lighting and ventilation are sufficient for the intended operation and fort of personnel. ? Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness. ? 照明以及通風必須足以使個人舒適和適應操作 ? 水供給，洗手間設備，地面排水渠道和排污系統(tǒng)必須足以滿足衛(wèi)生操作和設備清潔也必須滿足雇員個人的清潔 49 Cosmetic / Drug GMP’s美容及醫(yī)藥生產(chǎn)質(zhì)量操作管理規(guī)范 ? Equipment 設備 ? Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent. ? Utensils, transfer piping and cosmetic contact surfaces of equipment are wellmaintained and clean and are sanitized at appropriate intervals. ? Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination. ? 在處理，生產(chǎn)，流轉用途的設備和器具必須有適當?shù)脑O計，原料和工藝。 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險的具有實質(zhì)重要性的產(chǎn)品。 必須遵照美國聯(lián)邦政府食品，設備藥物管制規(guī)程 161。Objectives 培訓目的 o Introduction to GMP?s? o 良好生產(chǎn)操作規(guī)范（ GMP?s) 概述 o Why do we need GMP?s o 我們?yōu)槭裁葱枰?GMP?s？ o When to we use GMP?s? o 我們何時需要用到 GMP?s？ o General Overview of basic cGMP Requirements o CGMP基本要求總攬 o Key differences from the QMS o 與質(zhì)量管理體系的關鍵區(qū)別 o Implementing for success o 成功的方法 1 Introduction to GMP’s 良好生產(chǎn)操作規(guī)范引言 a. GMP?s defined b. History c. Applications d. GMP?s 定義 e. 歷史 f. 適用范圍 2 cGMP’s Overview最新食品及藥物生產(chǎn)質(zhì)量管理規(guī)范 概要 North Asia Quality Managers Meeting March 6, 2023 Taipei Taiwan 北亞質(zhì)量經(jīng)理會議 2023， 3， 6，臺北，臺灣 3 Current Good Manufacturing Practices (cGMP) 最新食品及藥物生產(chǎn)質(zhì)量管理規(guī)范 Good Manufacturing Practices are…. the current minimum guidelines for controlling the manufacturing, processing, packing and holding of drug products to assure that the products are safe for use, are properly identified, of proper strength, and of appropriate quantity and quality. 生產(chǎn)管理規(guī)范是指。 必須遵照美國公平包裝標式法 161。 Example of Class III device: 級別三的產(chǎn)品舉例： implantable pacemaker 植入式心臟起博器 18 ? Medical Device Reporting (21CFR 803) ? Corrections, Removals and Withdrawals (21CFR 806) ? Labeling (21CFR 801) ? Electronic Records, Electronic Signatures (21CFR 11) ? Registration Listing (21CFR 807) ? Quality System Regulation (21 CFR 820) with exemptions ? 醫(yī)療產(chǎn)品報告 ? 更正，解除 ? 標注 ? 電子記錄，電子簽名 ? 登記和名錄 ? 質(zhì)量體協(xié)規(guī)章（含免除部分） What FDA Regulations Apply? 美國聯(lián)邦政府食品藥物管理規(guī)定適用什么？ 19 ? CE Marking Medical Device Directive (MDD 93/42/EEC) if the product is distributed in the European Union ? Devices must meet the essential requirements in Annex I. ? Technical documentation is required as outlined in Annex VII ? CE mark is affixed to the product in accordance with the procedure described in Annex XII. ? CE標記 醫(yī)療產(chǎn)品指導，若該產(chǎn)品分售到歐洲聯(lián)盟 ? 產(chǎn)品必須符合必須的要求（見附錄 I） ? 技術文檔要求在附錄 VII概述 ? CE標記必須按照附錄 XII中描述的進程貼上 What Other Quality System Standards Apply?其他質(zhì)量體系標準適用什么？ 20 Cosmetic Products 美容用品 “ Articles, other than soap, intended to be rubbed, sprinkled, or sprayed on, introduced into or otherwise applied to the body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body?s structure or function.” 那些除了肥皂外用于使身體清潔美觀等的任何噴霧或洗滌用品，并對身體不造成任何的傷害。并通過以避免因灰塵等原因造成材料的腐蝕 ? 器具，運轉的管道和美容產(chǎn)品的生產(chǎn)設備必須間隔并整潔的放置 ? 整潔的便攜式設備和器具需被儲存，生產(chǎn)美容用品的設備需被遮蓋以避免灰塵等污染物 50 Cosmetic / Drug GMP’s ? Personnel ? The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/