【正文】 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。 select on basis of meeting requirements, document evaluation ? Define control based on evaluation results ? Establish amp。 services conform to specified requirements. Evaluations (suppliers, contractors, amp。 effective date 72 Medical Device cGMPs Subpart E – Purchasing Controls 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。 dates are documented 167。 Management Responsibility (continued) 69 Medical Device cGMPs Subpart B – Quality System Requirements Quality audit procedures shall be in place to assure: Quality system is in pliance Determination of effectiveness of system Quality audits Auditor shall be independent Corrective Actions taken Audit reports Audits amp。 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。 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。s group etc., to whom formula information and/or toxicity data are provided. ? Whether the firm voluntarily files Cosmetic Product Experience Reports (21 CFR 730). 61 Cosmetic / Drug GMP’s ? Other ? Participating in the program of voluntary registration of: ? Cosmetic manufacturing establishments (21 CFR 710). ? Cosmetic product ingredient and cosmetic raw material position statements (21 CFR 720). ? Cosmetic product experiences (21 CFR 730). ? Using a color additive which is not listed for use in cosmetics (21 CFR 73, 74, and 82) or which is not certified (21 CFR 80). ? Using a prohibited cosmetic ingredient (21 CFR 700). 62 Cosmetic / Drug GMP’s An appropriate quality system to meet the applicable regulations 63 Appendix B ? Medical Device GMP?s 64 Medical Device cGMPs General controls include: Establishment Registration (use FDA Form 2891) of panies which are required to register under 21 CFR Part , such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA. Medical Device Listing (use FDA Form 2892) with FDA of devices to be marketed. Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820. Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809. Submission of a premarket notification [510(k)] before marketing a device. 65 Medical Device cGMPs A medical device is: ? an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a ponent part, or accessory which is: ? recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, ? intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or ? intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it39。 49 Cosmetic / Drug GMP’s美容及醫(yī)藥生產質量操作管理規(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 50 Cosmetic / Drug GMP’s美容及醫(yī)藥生產質量操作管理規(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，流轉用途的設備和器具必須有適當?shù)脑O計，原料和工藝。 ? 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。 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 38 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 ? 產品歷史 39 Risk Assessment Scope 風險評估范圍 40 How do we assess GMP risks? 我們如何評估 GMP風險？ HACCP is a proactive systematic approach to the id